UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

____________________________________________________________________________________________

FORM 10-Q

_____________________________________________________________________________________________

☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the Quarterly Period Ended September 30, 2019

OR

☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the Transition Period from              to                 

Commission File Number 001-36189

_____________________________________________________________________________________________

Tandem Diabetes Care, Inc.

(Exact name of registrant as specified in its charter)

_____________________________________________________________________________________________

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)

(858) 366-6900

Registrant’s telephone number, including area code

Securities registered pursuant to Section 12(b) of the Act:

Title of Each Class	Symbol	Name of Exchange on Which Registered
Common Stock, par value $0.001 per share	TNDM	NASDAQ Global Market

_____________________________________________________________________________________________

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.    Yes  ☒    No  ☐

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).    Yes  ☒    No  ☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company or an emerging growth company. See definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

Large accelerated filer	x	Accelerated filer	☐
Non-accelerated filer	☐	Smaller reporting company	☐
		Emerging growth company	☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.                                                                                                          ☐

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).    Yes  ☐    No   ☒

As of October 30, 2019, there were 59,092,861 shares of the registrant’s Common Stock outstanding.

TABLE OF CONTENTS

Part I	Financial Information	1
Item 1	Financial Statements	1
	Condensed Consolidated Balance Sheets at September 30, 2019 (Unaudited) and December 31, 2018	1
	Condensed Consolidated Statements of Operations and Comprehensive Loss for the Three and Nine Months Ended September 30, 2019 and 2018 (Unaudited)	2
	Condensed Consolidated Statements of Stockholders’ Equity (Deficit) for the Three and Nine Months Ended September 30, 2019 and 2018	3
	Condensed Consolidated Statements of Cash Flows for the Nine Months Ended September 30, 2019 and 2018 (Unaudited)	5
	Notes to Unaudited Condensed Consolidated Financial Statements	6
Item 2	Management’s Discussion and Analysis of Financial Condition and Results of Operations	19
Item 3	Quantitative and Qualitative Disclosures about Market Risk	33
Item 4	Controls and Procedures	34
Part II	Other Information	35
Item 1	Legal Proceedings	35
Item 1A	Risk Factors	35
Item 2	Unregistered Sales of Equity Securities and Use of Proceeds	66
Item 3	Defaults Upon Senior Securities	66
Item 4	Mine Safety Disclosures	66
Item 5	Other Information	66
Item 6	Exhibits	67

PART I. FINANCIAL INFORMATION

Item 1. Financial Statements

TANDEM DIABETES CARE, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(In thousands, except par value)

	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

See accompanying notes to unaudited condensed consolidated financial statements.

1

TANDEM DIABETES CARE, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

(Unaudited)

(In thousands, except per share data)

	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

See accompanying notes to unaudited condensed consolidated financial statements.

2

TANDEM DIABETES CARE, INC.

CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY (DEFICIT)

(Unaudited)

(In thousands)

Three Months Ended September 30, 2019

	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

Nine Months Ended September 30, 2019

	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

See accompanying notes to unaudited condensed consolidated financial statements.

3

Three Months Ended September 30, 2018

	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

Nine Months Ended September 30, 2018

	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

See accompanying notes to unaudited condensed consolidated financial statements.

4

TANDEM DIABETES CARE, INC.

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(Unaudited)

(In thousands)

	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

See accompanying notes to unaudited condensed consolidated financial statements.

5

TANDEM DIABETES CARE, INC.

NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

1. Organization and Basis of Presentation

The Company

Tandem Diabetes Care, Inc. is a medical device company with an innovative approach to the design, development and commercialization of products for people with insulin-dependent diabetes. The Company is incorporated in the state of Delaware. Unless the context requires otherwise, the terms the “Company” or “Tandem” refer to Tandem Diabetes Care, Inc., together with its wholly-owned subsidiary in Canada.

The Company manufactures, sells and supports insulin pump products that are designed to address the evolving needs and preferences of differentiated segments of the insulin-dependent diabetes market. The Company’s manufacturing, sales and support activities principally focus on the t:slim X2 Insulin Delivery System (t:slim X2), the Company’s flagship pump platform which is capable of remote feature updates and is designed to display continuous glucose monitoring (CGM) sensor information directly on the pump home screen. The Company’s insulin pump products are compatible with the Tandem Device Updater, a Mac and PC-compatible tool for the remote update of the Company's insulin pump software. The Company’s insulin pump products are generally considered durable medical equipment and have an expected lifespan of at least four years. In addition to insulin pumps, the Company sells disposable products that are used together with the pumps and are replaced every few days, including cartridges for storing and delivering insulin, and infusion sets that connect the insulin pump to a user’s body.

The Company began commercial sales of its first product, t:slim, in August 2012 and subsequently commercialized t:flex in May 2015, t:slim G4 in September 2015 and t:slim X2 in October 2016. The t:slim X2 hardware platform now represents 100% of new pump shipments, but the Company continues to provide ongoing service and support to existing t:slim, t:slim G4 and t:flex customers. In August 2017, the Company received approval from the United States Food and Drug Administration (FDA) for the integration of t:slim X2 with the Dexcom G5 Mobile CGM system. In June 2018, the Company received FDA approval for t:slim X2 with Basal-IQ technology, the Company’s first-generation Automated Insulin Delivery (AID) algorithm, and the first insulin pump designated as compatible with integrated CGM (known as iCGM) devices. The Company commenced commercial sales of t:slim X2 with Basal-IQ technology integrated with the Dexcom G6 CGM in August 2018.

During the third quarter of 2018, the Company commenced sales of the t:slim X2 with G5 integration through distribution partners in select European countries, in addition to Australia, New Zealand and South Africa. Direct sales efforts in Canada began in the fourth quarter of 2018. During the second quarter of 2019, the Company began selling the t:slim X2 with Basal-IQ technology in select geographies outside of the United States.

As of September 30, 2019, the Company had $156.9 million in cash, cash equivalents and short-term investments. The Company has incurred operating losses since its inception and had an accumulated deficit of $627.5 million as of September 30, 2019, which included a net loss of $27.4 million for the nine months ended September 30, 2019. Management believes that the cash, cash equivalents and short-term investments on hand will be sufficient to satisfy the Company’s liquidity requirements for at least the next 12 months from the date of this filing.

The Company’s ability to execute on its business strategy, meet its future liquidity requirements, and achieve and maintain profitable operations, is dependent on a number of factors, including its ability to continue to gain market acceptance of its products and achieve a level of revenues adequate to support its cost structure, achieve renewal pump sales objectives, develop and launch new products, expand the commercialization of products into new international markets, maximize manufacturing efficiencies, satisfy increasing production requirements, leverage the investments made in its sales, clinical, marketing and customer support organizations, and operate its business and manufacture and sell products without infringing on third party intellectual property rights.

6

The Company has funded its operations primarily through private and public offerings of equity securities, and through debt financing which has since been fully repaid. The Company may in the future seek additional capital from public or private offerings of equity or debt securities, or it may elect to borrow capital under new credit arrangements or from other sources. If the Company issues equity or debt securities to raise additional funds, its existing stockholders may experience dilution, it may incur significant financing or debt service costs, and the new equity or debt securities may have rights, preferences and privileges senior to those of its existing stockholders. There can be no assurance that equity or debt financing will be available on acceptable terms, or at all.

Basis of Presentation

The Company has prepared the accompanying unaudited condensed consolidated financial statements in accordance with accounting principles generally accepted in the United States of America (U.S. GAAP) for interim financial information and pursuant to the instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, they do not include all of the information and disclosures required by U.S. GAAP for complete financial statements. In the opinion of management, all adjustments which are of a normal and recurring nature, considered necessary for a fair presentation of the financial information contained herein, have been included.

Interim financial results are not necessarily indicative of results anticipated for the full year or any other period(s). These unaudited condensed consolidated financial statements should be read in conjunction with the Company’s audited consolidated financial statements and accompanying notes included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2018 (Annual Report), from which the balance sheet information herein was derived.

The condensed consolidated financial statements include the accounts of Tandem Diabetes Care, Inc. and its wholly owned subsidiary in Canada. All significant intercompany balances and transactions have been eliminated in consolidation.

2. Summary of Significant Accounting Policies

There have been no material changes to the Company's significant accounting policies during the nine months ended September 30, 2019, as compared to those disclosed in the Annual Report other than adoption of the new lease accounting standard effective January 1, 2019 (See Note 6, “Leases”).

Use of Estimates

The preparation of the consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and judgments that affect the reported amounts of assets, liabilities, revenues and expenses and the disclosure of contingent assets and liabilities in the Company’s consolidated financial statements and accompanying notes as of the date of the consolidated financial statements. Some of those judgments can be subjective and complex, and therefore, actual results could differ materially from those estimates under different assumptions or conditions.

Segment Reporting

Operating segments are identified as components of an enterprise about which discrete financial information is available for evaluation by the chief operating decision-maker (CODM) in making decisions regarding resource allocation and assessing performance. The Company’s current product offering consists primarily of insulin pumps, disposable cartridges and infusion sets for the storage and delivery of insulin. The Company views its operations and manages its business as one segment as key operating decisions and resource allocations are made by the CODM using consolidated financial data.

Accounts Receivable

The Company grants credit to various customers in the ordinary course of business and is paid directly by customers who use the products, distributors and third-party insurance payors. The Company maintains an allowance for doubtful accounts for potential credit losses. Provisions are made based on historical experience, assessment of specific risk, review of outstanding invoices, and various assumptions and estimates that are believed to be reasonable under the circumstances. Uncollectible accounts are written off against the allowance after appropriate collection efforts have been exhausted and when it is deemed that a balance is uncollectible.

7

Fair Value of Financial Instruments

The Company believes the carrying amounts of cash and cash equivalents, accounts receivable, accounts payable, accrued expenses, and employee-related liabilities are reasonable estimates of their fair values because of the short-term nature of these assets and liabilities. Short-term investments are carried at fair value. The Company believes the fair value of its operating lease liabilities at September 30, 2019 approximated their carrying value, based on the borrowing rates that were available for loans with similar terms as of that date. The estimated fair value of certain of the Company’s common stock warrants was determined using a Black-Scholes pricing model as of September 30, 2019 and December 31, 2018 (see Note 5, “Fair Value Measurements”).

Revenue Recognition

Revenue is generated primarily from sales of insulin pumps, disposable cartridges and infusion sets to individual customers and third-party distributors that resell the products to insulin-dependent diabetes customers.

In January 2018, the Company adopted the Revenue from Contracts with Customers Standard which superseded existing revenue guidance under U.S. GAAP and International Financial Reporting Standards. Pursuant to the Revenue from Contracts with Customers Standard’s core principle, subsequent to January 1, 2018, the Company recognizes revenue when it transfers promised goods or services to customers in an amount that reflects the consideration to which the Company expects to be entitled in exchange for those goods or services. The Company elected to implement this new standard utilizing the modified retrospective method. Under this approach, the Company applied the new standard to all new contracts initiated on or after the effective date, and for contracts which had remaining obligations as of the effective date the Company recorded an adjustment to the opening balance of accumulated deficit. The accounting for the significant majority of the Company’s revenues was not impacted by the new guidance. On January 1, 2018, the Company recorded a net reduction to accumulated deficit in the amount of $149,000, to reflect the impact of the accounting change. Prior to the implementation of this new standard, revenue was recognized when persuasive evidence of an arrangement existed, delivery had occurred and title passed, the price was fixed or determinable, and collectability was reasonably assured.

The Company considers the individual deliverables in its product offering as separate performance obligations. The transaction price is determined based on the consideration expected to be received, based either on the stated value in contractual arrangements or the estimated cash to be collected in non-contracted arrangements. The Company allocates the consideration to the individual performance obligations and recognizes the consideration based on when the performance obligation is satisfied, considering whether or not this occurs at a point in time or over time. Generally, insulin pumps, cartridges, infusion sets and accessories are deemed performance obligations that are satisfied at a point in time when the customer obtains control of the promised good, which is upon delivery, while access to the complementary products, such as the t:connect cloud-based data management application and the Tandem Device Updater, are considered performance obligations satisfied over the typical four-year warranty period of the insulin pumps. There is no standalone value for these complementary products. Therefore, the Company determines their value by applying the expected cost plus a margin approach and then allocates the residual to the insulin pumps. At September 30, 2019 and December 31, 2018, $7.6 million and $3.8 million, respectively, were recorded as deferred revenue for these performance obligations that are satisfied over time.

Additionally, the Company offers a 30-day right of return to its customers from the date of shipment of any of its insulin pumps, provided a physician’s confirmation of the medical reason for the return is received. Estimated allowances for sales returns are based on historical returned quantities as compared to pump shipments in those same periods of return. The return rate is then applied to the sales of the current period to establish a reserve at the end of the period. The return rates used in the reserve are adjusted for known or expected changes in the marketplace when appropriate. The allowance for sales returns is recorded as a reduction of revenue and an increase in deferred revenue in the period in which the related sale is recorded. The amount recorded on the Company’s balance sheets for allowance for sales returns was $0.2 million and $0.3 million at September 30, 2019 and December 31, 2018, respectively. Actual product returns have not differed materially from estimated amounts reserved in the accompanying condensed consolidated financial statements.

8

Warranty Reserve

The Company generally provides a four-year warranty on its insulin pumps to end user customers and may replace any pumps that do not function in accordance with the product specifications. Insulin pumps returned to the Company may be refurbished and redeployed. Additionally, the Company offers a six-month warranty on disposable cartridges and infusion sets. Estimated warranty costs are recorded at the time of shipment. Warranty costs are estimated based on the current expected product replacement cost and expected replacement rates based on historical experience. The Company evaluates the reserve quarterly and makes adjustments when appropriate. Changes to the actual replacement rates or the expected product replacement cost could have a material impact on the Company’s estimated warranty reserve. 

As of September 30, 2019 and December 31, 2018, the warranty reserve was $16.1 million and $9.1 million, respectively. The following table provides a reconciliation of the change in product warranty liabilities from December 31, 2018 through September 30, 2019 (in thousands):

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

Stock-Based Compensation

Stock-based compensation cost is measured at the grant date based on the estimated fair value of the award, and the portion that is ultimately expected to vest is recognized as compensation expense over the requisite service period on a straight-line basis. The Company estimates the fair value of stock options issued under the Company’s Amended and Restated 2013 Stock Incentive Plan (2013 Plan), and the fair value of the employees’ purchase rights under the Company’s 2013 Employee Stock Purchase Plan (ESPP), using the Black-Scholes option-pricing model on the date of grant. The Black-Scholes option-pricing model requires the use of assumptions about a number of variables, including stock price volatility, expected term, dividend yield and risk-free interest rate. For awards that vest based on the achievement of service conditions, the Company recognizes expense using the straight-line method less estimated forfeitures based on historical experience.

Net Loss Per Share

Basic net loss per share is calculated by dividing the net loss by the weighted average number of shares of common stock that were outstanding for the period, without consideration of common stock equivalents. Diluted net loss per share is calculated in accordance with the treasury stock method and reflects the potential dilution that would occur if outstanding securities or other contracts to issue common stock were exercised or converted to common stock. Dilutive common stock equivalents are comprised of warrants, potential awards granted pursuant to the ESPP, and stock options outstanding under the Company’s equity incentive plans. For warrants that are recorded as a liability in the accompanying balance sheets, the calculation of diluted net loss per share requires that, to the extent the average market price of the underlying shares for the reporting period exceeds the exercise price of the warrants and the presumed exercise of the warrants is dilutive to loss per share for the period, an adjustment be made to net loss used in the calculation to remove the change in fair value of the warrants from the numerator for the period. Likewise, an adjustment to the denominator is required to reflect the related dilutive shares, if any, under the treasury stock method. For all periods presented other than the three months ended September 30, 2019, there is no difference in the number of shares used to calculate basic and diluted shares outstanding due to the Company’s net loss position. For the three months ended September 30, 2019, the net loss used in the calculation of diluted net loss per share was increased by $2.3 million to remove the decrease in fair value of common stock warrants based on the dilutive effect of assumed exercise, and the denominator was increased by 394,433 shares calculated under the treasury stock method.

9

Potentially dilutive securities not included in the calculation of diluted net loss per share (because inclusion would be anti-dilutive) are as follows (in thousands, in common stock equivalent shares):

	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

Recent Accounting Pronouncements

In June 2016, the Financial Accounting Standards Board (FASB) issued Accounting Standards Update (ASU) No. 2016-13, Financial Instruments – Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments, which modifies the measurement and recognition of credit losses for most financial assets and certain other instruments. The new standard requires the use of forward-looking expected credit loss models based on historical experience, current conditions, and reasonable and supportable forecasts that affect the collectability of the reported amount, which may result in earlier recognition of credit losses under the new standard. The new standard also requires that credit losses related to available-for-sale debt securities be recorded as an allowance through net income (loss) rather than reducing the carrying amount under the current, other-than-temporary-impairment model. The standard is effective for public business entities for annual periods beginning after December 15, 2019, and interim periods within those years. The Company plans to implement the new standard in the first quarter of 2020, and is in the process of reviewing its credit loss models to assess the impact of the adoption of the standard on its consolidated financial statements.

In August 2018, the FASB issued ASU No. 2018-13, Fair Value Measurement: Disclosure Framework – Changes to the Disclosure Requirements for Fair Value Measurement, which adds and modifies certain disclosure requirements for fair value measurements. Under the new guidance, entities will no longer be required to disclose the amount of and reasons for transfers between Level 1 and Level 2 of the fair value hierarchy, or valuation processes for Level 3 fair value measurements. However, public companies will be required to disclose the range and weighted average of significant unobservable inputs used to develop Level 3 fair value measurements, and related changes in unrealized gains and losses included in other comprehensive income. The updated guidance is effective for annual periods beginning after December 15, 2019, and interim periods within those periods, with early adoption permitted. The Company is in the process of assessing the impact of the adoption of the updated guidance on its consolidated financial statements, as well as whether to early adopt the new standard.

In August 2018, the FASB issued ASU No. 2018-15, Customer's Accounting for Implementation Costs Incurred in a Cloud Computing Arrangement That Is a Service Contract, which changes the accounting for implementation costs incurred in a cloud computing arrangement that is a service contract. The updated guidance aligns the requirements for capitalizing implementation costs incurred in a hosting arrangement with the requirements for capitalizing implementation costs incurred to develop or obtain internal-use software. The implementation costs should be presented as a prepaid asset on the balance sheets and expensed over the term of the hosting arrangement. The updated guidance is effective for annual periods beginning after December 15, 2019, and interim periods within those periods, with early adoption permitted. The Company is in the process of assessing the impact of the adoption of the updated guidance on its consolidated financial statements.

10

3. Short-Term Investments

The Company invests in marketable securities, principally debt instruments of the U.S. Government, and financial institutions and corporations with strong credit ratings. The following represents a summary of the estimated fair value of short-term investments as of September 30, 2019 and December 31, 2018 (in thousands):

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

The Company has classified all marketable securities, regardless of maturity, as short-term investments based upon the Company's ability and intent to use any and all of those marketable securities to satisfy the Company's current liquidity requirements.

The Company periodically reviews the portfolio of available-for-sale debt securities to determine if any investment is other-than-temporarily impaired due to changes in credit risk or other potential valuation concerns. The Company believes that the short-term investments held at September 30, 2019 were not other-than-temporarily impaired. Unrealized losses on available-for-sale debt securities at that date were not significant and were due to changes in interest rates, including credit spreads, and not due to increased credit risks associated with specific securities. The Company does not intend to sell the available-for-sale debt securities that are in an unrealized loss position, and it is not more likely than not that the Company will be required to sell these debt securities before recovery of their amortized cost bases, which may be at maturity.

4. Inventories

Inventories consisted of the following as of September 30, 2019 and December 31, 2018 (in thousands):

	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

11

5. Fair Value Measurements

Authoritative guidance on fair value measurements defines fair value and provides a consistent framework for both measuring fair value as well as for disclosures of each major asset and liability category measured at fair value on either a recurring or a nonrecurring basis. Fair value is intended to reflect an assumed exit price, representing the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants. As such, fair value is a market-based measurement that should be determined based on assumptions that market participants would use in pricing an asset or liability. As a basis for considering such assumptions, the authoritative guidance provides a three-tier fair value hierarchy, which prioritizes the inputs used in measuring fair value as follows:

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.

The following table presents information about the Company’s financial assets and liabilities measured at fair value on a recurring basis as of September 30, 2019 and December 31, 2018, and indicates the fair value hierarchy of the valuation techniques utilized by the Company to determine such fair value (in thousands):  

			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

12

(1) Generally, cash equivalents include money market funds and investments with a maturity of three months or less from the date of purchase.

The Company’s Level 2 financial instruments are valued using market prices on less active markets with observable valuation inputs such as interest rates and yield curves. The Company obtains the fair value of Level 2 financial instruments from quoted market prices, calculated prices or quotes from third-party pricing services. The Company validates these prices through independent valuation testing and review of portfolio valuations provided by the Company’s investment managers. There were no transfers between Level 1 and Level 2 assets during the nine months ended September 30, 2019 and 2018.

The Company’s Level 3 liabilities at September 30, 2019 and December 31, 2018 include the Series A warrants issued by the Company in connection with the public offering of common stock in October 2017. The Series A warrants have a term of five years and initially provided holders the right to purchase 4,630,000 shares of the Company’s common stock at an exercise price of $3.50 per share. The Series A warrants were initially valued in the aggregate amount of $5.2 million on the date of issuance utilizing a Black-Scholes pricing model.

The Company reassesses the fair value of the outstanding Series A warrants at each reporting date utilizing a Black-Scholes pricing model. Variables used in the pricing model include the market price of the Company’s common stock and estimates of stock price volatility, dividend yield, expected warrant term and risk-free interest rate. The Company develops its estimates based on publicly available historical data. The assumptions used to estimate the fair values of the outstanding Series A warrants at September 30, 2019 and December 31, 2018 are presented below:

	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

The following table presents a summary of changes in the fair value of the Company’s Level 3 financial liabilities for the nine months ended September 30, 2019 and 2018:

	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

During the nine months ended September 30, 2019, the Company issued 93,470 shares of common stock upon the exercise of Series A warrants. During the nine months ended September 30, 2018, the Company issued 8,598,076 shares of common stock upon the exercise of certain warrants issued in October 2017, and 13,450 warrants expired unexercised. As of September 30, 2019, there were Series A warrants outstanding to purchase 417,315 shares of the Company's common stock (see Note 8, “Stockholders’ Equity”).

13

6. Leases

In February 2016, the FASB issued ASU No. 2016-02, Leases. The new standard and its related amendments (collectively referred to as ASC 842) requires lessees to recognize right-of-use assets and corresponding lease liabilities for all leases with lease terms of greater than 12 months. It also changed the definition of a lease and expanded the disclosure requirements of lease arrangements. In July 2018, the FASB added a transition option for implementation of the standard that allowed companies to continue to use the legacy guidance in ASC 840, Leases, including its disclosure requirements, in the comparative periods presented in the year of adoption. The new standard must be adopted using the modified retrospective approach and was effective for the Company starting in the first quarter of fiscal 2019. The Company elected the transition option and certain practical expedients, and recognized a cumulative-effect transition adjustment for the recognition of right-of-use leased assets and corresponding operating lease liabilities of $12.4 million on the consolidated balance sheets upon adoption of the standard as of January 1, 2019. The Company did not restate prior periods. Deferred rent of $1.0 million and $3.8 million as of January 1, 2019 was reclassified from other current liabilities and deferred rent long-term, respectively, to a reduction of the right-of-use leased assets in connection with the adoption of the standard.

The Company's leases consist primarily of operating leases for general office space, laboratory, manufacturing, and warehouse facilities, and equipment. Leases with an initial term of 12 months or less are not recorded on the balance sheets. The Company recognizes lease expense for these leases on a straight-line basis over the lease term. Because the Company's leases do not provide an implicit interest rate, the Company uses its incremental borrowing rate based on the information available at the lease commencement date in determining the present value of future lease payments. The Company used the incremental borrowing rate on January 1, 2019 for operating leases that commenced prior to that date. For lease agreements entered into or reassessed after the adoption of ASC 842, the Company combines lease and non-lease components.

Certain leases include an option to renew, with renewal terms that can extend the lease term for additional periods. The exercise of lease renewal options is at the Company's sole discretion. The depreciable life of assets and leasehold improvements are limited by the expected lease term, unless there is a transfer of title or purchase option that is reasonably certain to be exercised.

In January 2019, the Company entered into a lease agreement for approximately 25,332 square feet of additional general administrative office space (Initial Premises) located at 10935 Vista Sorrento Parkway, San Diego, California (Vista Sorrento Parkway Lease). The lease term for the Initial Premises commenced in March 2019 and expires in September 2022. In May 2019, the Company entered into a First Amendment to the Vista Sorrento Parkway Lease (First Amendment) to expand the leased premises by adding approximately 33,681 square feet of additional general administrative office space (Expansion Space), and to extend the lease term for the Initial Premises through December 2022. The lease term for the Expansion Space commenced in May 2019 and expires in December 2022. The Company has a one-time option to extend the term of the Vista Sorrento Parkway Lease, covering both the Initial Premises and the Expansion Space, for a period of four years. The Company recognized right-of-use leased assets and corresponding operating lease liabilities of $3.1 million on the consolidated balance sheets in the first quarter of 2019 related to the Initial Premises, and $4.5 million in the second quarter of 2019 related to the First Amendment to the Vista Sorrento Parkway Lease.

In March 2019, the Company entered into a lease agreement for approximately 40,490 square feet of space located at 6495 Marindustry Place, San Diego, California to house additional operations functions, including warehousing and shipping (Marindustry Place Lease). The lease term commenced in May 2019 and expires in April 2026. The Company has a one-time option to extend the term of the Marindustry Place Lease for a period of no less than three years and no more than five years. The Company recognized right-of-use leased assets and corresponding operating lease liabilities of $3.4 million on the consolidated balance sheets in the second quarter of 2019 related to the Marindustry Place Lease.

14

Future minimum lease payments under non-cancellable operating leases as of September 30, 2019 were as follows (in thousands):

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

7. Term Loan Agreement

In August 2018, the Company fully repaid the term loan made by Capital Royalty Partners II, L.P. and its affiliated funds (CRG) pursuant to the Amended and Restated Term Loan Agreement (Term Loan Agreement). The balance of the outstanding debt during 2018 up until the time of repayment was $82.7 million. The repayment included approximately $1.1 million in accrued interest and approximately $5.0 million in associated financing fees that became due. As a result of the repayment, the Company did not have any borrowings outstanding under the Term Loan Agreement as of September 30, 2019 or December 31, 2018.

Under the Term Loan Agreement, interest was payable at the Company’s option, (i) in cash at a rate of 11.5% per annum, or (ii) at a rate of 9.5% of the 11.5% per annum in cash and 2.0% of the 11.5% per annum (PIK Loan) to be added to the principal of the loan and subject to accruing interest.

The Company entered into a series of amendments to the Term Loan Agreement between 2016 and 2018, which included the addition of a financing fee payable at the maturity of the Company’s loans, the issuance of 193,788 ten-year warrants to CRG to purchase shares of the Company’s common stock at an exercise price of $23.50 per share and certain other minimum financing covenants. The financing fee was applicable to the entire aggregate principal amount of borrowings outstanding, including total PIK Loans issued. As of September 30, 2019, the warrants to purchase 193,788 shares of the Company's common stock at an exercise price of $23.50 per share remained outstanding.

8. Stockholders’ Equity

Public Offerings

In the first quarter of 2018, the Company completed a public offering of 34,500,000 shares of common stock at a public offering price of $2.00 per share. The gross proceeds to the Company from the offering were approximately $69.0 million, before deducting underwriting discounts and commissions and other offering expenses payable by the Company.

In the third quarter of 2018, the Company completed a public offering of 4,035,085 shares of common stock at a public offering price of $28.50 per share. The gross proceeds to the Company from the offering were $115.0 million, before deducting underwriting discounts and commissions and other offering expenses payable by the Company.

15

Shares Reserved for Future Issuance

The following shares of the Company’s common stock were reserved for future issuance as of September 30, 2019 (in thousands):

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

As of September 30, 2019, there were Series A warrants outstanding to purchase 417,315 shares of the Company's common stock at an exercise price of $3.50 per share, which were issued in connection with the October 2017 Financing, and which expire in October 2022. Also outstanding as of September 30, 2019, were warrants to purchase 193,788 shares of the Company's common stock at an exercise price of $23.50 per share, which were issued in March 2017, and which expire in March 2027 (see Note 7, “Term Loan Agreement”), and warrants to purchase 98,965 shares of the Company's common stock at an exercise price of $73.73 per share, which were issued between August 2011 and August 2012, and which expire between August 2021 and August 2022. The Company issued 200 and 93,470 shares of its common stock upon the exercise of warrants during the three and nine months ended September 30, 2019, respectively. The Company issued 8,603,321 shares of its common stock upon the exercise of warrants during the year ended December 31, 2018.

In both June 2019 and 2018, the Company received approval from its stockholders to increase the number of shares of its common stock reserved for issuance under the 2013 Plan by 5,000,000 and 5,500,000 shares, respectively. The Company issued 439,646 and 1,213,428 shares of its common stock upon the exercise of stock options during the three and nine months ended September 30, 2019, respectively. The Company issued 136,042 shares of its common stock upon the exercise of stock options during the year ended December 31, 2018.

The ESPP enables eligible employees to purchase shares of the Company's common stock using their after-tax payroll deductions, subject to certain conditions. Historically, offerings under the ESPP consisted of a two-year offering period with four six-month purchase periods which begin in May and November of each year. The Company previously suspended the ESPP in May 2017 due to a lack of available shares. In June 2018, the Company received approval from its stockholders to increase the number of shares of its common stock reserved for issuance under the ESPP by 2,000,000 shares. A new offering commenced under the ESPP on June 15, 2018, and the first purchase date was November 15, 2018. There were 168,165 shares of common stock purchased under the ESPP in the nine months ended September 30, 2019. There were 80,581 shares of common stock purchased under the ESPP during the year ended December 31, 2018.

Stock-Based Compensation

In June 2019, the Company granted options to purchase 1,644,715 shares of common stock under the 2013 Plan, which were originally awarded between February 2019 and June 2019, subject to and conditioned upon the approval by its stockholders of an increase in the number of shares of common stock reserved for issuance under the 2013 Plan. In total, the Company granted options to purchase 2,916,906 shares of common stock under the 2013 Plan during the nine months ended September 30, 2019. These options have an exercise price equal to the closing price of the Company's common stock on the applicable award date, and generally vest as to 25% of the underlying shares on the first anniversary of the award, with the balance of the options vesting monthly over the following three years.

In June 2018, the Company granted options to purchase 811,800 shares of common stock under the 2013 Plan, which were originally awarded on December 1, 2017, subject to and conditioned upon the approval by its stockholders of an increase in the number of shares of common stock authorized under the 2013 Plan. These options have an exercise price equal to the closing price of the Company's common stock on the applicable award date, and generally vest as to 50% of the underlying shares on the first anniversary of the award, with the balance of the options vesting monthly over the following year.

16

The Company also granted options to purchase 3,661,220 shares of common stock under the 2013 Plan during the nine months ended September 30, 2018. These options have an exercise price equal to the closing price of the Company's common stock on the applicable award date, and generally vest as to 25% of the underlying shares on the first anniversary of the award, with the balance of the options vesting monthly over the following three years, except with respect to options to purchase 3,389,300 shares of common stock granted in June 2018, which vest as to 50% of the underlying shares on the first anniversary of the award, with the balance of the options vesting monthly over the following year.

The assumptions used in the Black-Scholes option-pricing model are as follows:

	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		%