What changed in this filing

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Item 1. Financial Statements

2020-10-27 compared with 2020-07-30 · 128 added, 119 removed, 444 unchanged (36% of the section changed)

3 unchanged sentences

(In thousands, except share amounts)

September 30,

Current assets:

1 unchanged sentence

Short-term investments

Receivable related to Daiichi Sankyo license agreements

Accounts receivable, net

2 unchanged sentences

Property and equipment, net

Investment in Arcturus equity securities

Investments in equity securities

Long-term investments

5 unchanged sentences

Accrued liabilities

Short-term contract liability

Contract liabilities, net

Short-term lease liabilities

Total current liabilities

Long-term contract liability

Long-term lease liabilities

4 unchanged sentences

Preferred stock — 25,000,000 shares authorized;

nil outstanding as of June 30, 2020 and

nil outstanding as of September 30, 2020 and

December 31, 2019

1 unchanged sentence

60,815,690 and 57,838,220 shares issued

and outstanding as of June 30, 2020 and December 31, 2019, respectively

and outstanding as of September 30, 2020 and December 31, 2019, respectively

Additional paid-in capital

7 unchanged sentences

(In thousands, except share and per share amounts)

Three Months Ended June 30,

Six Months Ended June 30,

Three Months Ended September 30,

Nine Months Ended September 30,

Collaboration and license

9 unchanged sentences

Interest income

Change in fair value of investment in Arcturus equity securities

Change in fair value of investments in equity securities

Non-cash interest expense on liability related to the sale of future

Other income (expense)

Income (loss) before income taxes

Loss before income taxes

Provision for income taxes

Net income (loss)

Net income (loss) per share:

Weighted-average shares used in computing net income (loss)

Net loss per share, basic and diluted

Weighted-average shares used in computing net loss per share,

basic and diluted

See accompanying notes.

ULTRAGENYX PHARMACEUTICAL INC.

CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME (LOSS)

CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS

(In thousands)

Three Months Ended June 30,

Six Months Ended June 30,

Net income (loss)

Three Months Ended September 30,

Nine Months Ended September 30,

Other comprehensive income:

Foreign currency translation adjustments

Unrealized gain on available-for-sale securities

Other comprehensive income

Total comprehensive income (loss)

Unrealized gain (loss) on available-for-sale securities

Other comprehensive income (loss)

Total comprehensive loss

See accompanying notes.

5 unchanged sentences

Income (Loss)

Balance as of March 31, 2020

Issuance of common stock in connection with

at-the-market offering, net of issuance costs

Balance as of June 30, 2020

Employee stock-based compensation

1 unchanged sentence

plan awards, net of tax

Other comprehensive income

Balance as of June 30, 2020

Other comprehensive loss

Balance as of September 30, 2020

Comprehensive

10 unchanged sentences

Other comprehensive income

Balance as of June 30, 2020

Balance as of September 30, 2020

Comprehensive

1 unchanged sentence

Income (Loss)

Balance as of March 31, 2019

Issuance of common stock in connection with

at-the-market offering, net of issuance costs

Balance as of June 30, 2019

Employee stock-based compensation

1 unchanged sentence

awards, net of tax

Other comprehensive income

Balance as of June 30, 2019

Other comprehensive loss

Balance as of September 30, 2019

ULTRAGENYX PHARMACEUTICAL INC.

14 unchanged sentences

Other comprehensive income

Balance as of June 30, 2019

Balance as of September 30, 2019

See accompanying notes.

2 unchanged sentences

(In thousands)

Six Months Ended June 30,

Nine Months Ended September 30,

Operating activities:

1 unchanged sentence

Stock-based compensation

Amortization of discount on investment securities, net

Amortization of premium (discount) on investment securities, net

Depreciation and amortization

Foreign currency remeasurement (gain) loss

Change in fair value of investment in Arcturus equity securities

Foreign currency remeasurement loss

Change in fair value of investments in equity securities

Non-cash collaboration royalty revenue

3 unchanged sentences

Prepaid expenses and other assets

Receivable related to the Daiichi Sankyo license agreement

Right-of-use assets

Accounts payable, accrued, and other liabilities

Contract liabilities

Contract liabilities, net

Lease liabilities

3 unchanged sentences

Purchase of investments

Purchase of investment in Arcturus equity securities

Purchase of investments in equity securities

Purchase of convertible notes receivable

Proceeds from the sale of investments

Proceeds from maturities of investments

Payment for intangible assets

Net cash used in investing activities

23 unchanged sentences

Food and Drug Administration (FDA) and in Canada for the treatment of X-linked hypophosphatemia (XLH) in adult and pediatric patients one year of age and older, and has received European conditional marketing authorization for the treatment of XLH with radiographic evidence of bone disease in children one year of age and older and adolescents with growing skeletons.

In October 2020, this authorization was expanded to include older adolescents and adults.

In Brazil, Crysvita is approved for treatment of XLH in adult and pediatric patients one year of age and older.

10 unchanged sentences

The Company’s ultimate success depends on the outcome of its research and development and commercialization activities, for which it expects to incur additional losses in the future.

Management recognizes that we will likely need to raise additional capital to fully implement its business plans.

Through June 30, 2020, the Company has relied primarily on the proceeds from equity offerings and its sale of future royalties to finance its operations.

Management recognizes that the Company will likely need to raise additional capital to fully implement its business plans.

Through September 30, 2020, the Company has relied primarily on the proceeds from equity offerings and its sale of future royalties to finance its operations.

The Company will likely raise additional capital through the issuance of equity, borrowings, or strategic alliances with partner companies.

8 unchanged sentences

These financial statements should be read in conjunction with the audited financial statements and notes thereto for the preceding fiscal year contained in the Company’s Annual Report on Form 10-K filed on February 14, 2020 with the United States Securities and Exchange Commission (SEC).

The results of operations for the three and six months ended June 30, 2020 are not necessarily indicative of the results to be expected for the year ending December 31, 2020.

The results of operations for the three and nine months ended September 30, 2020 are not necessarily indicative of the results to be expected for the year ending December 31, 2020.

The Condensed Consolidated Balance Sheet as of December 31, 2019 has been derived from audited financial statements at that date, but does not include all of the information required by GAAP for complete financial statements.

8 unchanged sentences

The following table provides a reconciliation of cash, cash equivalents, and restricted cash reported within the consolidated balance sheets that sum to the total of the same such amounts shown in the consolidated statement of cash flows (in thousands):

September 30,

Cash and cash equivalents

15 unchanged sentences

The Company considered the current and expected future economic and market conditions surrounding the novel coronavirus (COVID-19) pandemic and determined that the estimate of credit losses was not significantly impacted.

The adoption of ASU 2016-13 did not have a material impact on the Condensed Consolidated Financial Statements and related disclosures and there was no allowance for losses on available-for-sale debt securities which were attributable to credit risk for the three and six months ended June 30, 2020.

Revenue Recognition

41 unchanged sentences

The following tables set forth the fair value of the Company’s financial assets remeasured on a recurring basis based on the three-tier fair value hierarchy (in thousands):

June 30, 2020

September 30, 2020

Money market funds

Repurchase agreements

Time deposits

3 unchanged sentences

Government Treasury and agency securities

Investment in Arcturus equity security

Investment in Arcturus common stock

December 31, 2019

8 unchanged sentences

The Company determined the fair value of the Arcturus Therapeutics Holdings Inc.

(Arcturus) common stock by using the quoted market price on June 30, 2020, which is a Level 1 fair value measurement.

T he fair value of the option to purchase additional shares of Arcturus common stock was based on unobservable inputs that are significant to the measurement of the fair value of the asset and is supported by little or no market data;

accordingly, the fair value of the option is considered a Level 3 financial asset.

The Company measured the fair value of the option by applying the Black-Scholes option pricing method and utilizing the following inputs:

stock price, strike price, volatility, risk-free interest rate, and expected term.

The expected term was the Company’s estimated period to purchase additional stock.

In May 2020, the Company exercised its option to purchase additional shares of Arcturus common stock.

(Arcturus) common stock by using the quoted market price on September 30, 2020, which is a Level 1 fair value measurement.

See Note 6 for additional details on the Arcturus transaction.

In July 2020, the Company invested $ 2.5 million in DiaCarta Ltd.

(DiaCarta), a private diagnostic company, in the form of a convertible promissory note that matures in two years , if not converted earlier.

The Company was also issued a warrant to purchase up to $ 1.0 million of DiaCarta preferred stock.

The fair value of the warrant to purchase shares of DiaCarta was based on unobservable inputs that are significant to the measurement of the fair value of the asset and is supported by little or no market data;

accordingly, the warrant is considered a Level 3 financial asset and is remeasured on a nonrecurring basis.

The Company measured the fair value of the warrant by applying the Black-Scholes option pricing method and utilizing the following inputs:

stock price, strike price, volatility, risk-free interest rate, and expected term.

The Company will recognize interest income on the convertible promissory note based on the effective interest rate method over the life of the note.

As of September 30, 2020, the balance of the convertible promissory note was $ 2.0 million, including $ 0.1 million in interest receivable, and was recorded in other assets, and the allocated fair value of the warrant was $ 0.6 million and was recorded in investments in equity securities.

Balance Sheet Components

1 unchanged sentence

The fair values of cash equivalents and investments classified as available-for-sale securities consisted of the following (in thousands):

June 30, 2020

September 30, 2020

Gross Unrealized

Money market funds

Repurchase agreements

Time deposits

12 unchanged sentences

Government Treasury and agency securities

At June 30, 2020, the remaining contractual maturities of available-for-sale securities were less than two years .

There have been no realized gains or losses on available-for-sale securities for the three and six months ended June 30, 2020 and 2019.

All marketable securities with unrealized losses at June 30, 2020 have been in a loss position for less than twelve months.

At September 30, 2020, the remaining contractual maturities of available-for-sale securities were less than one year .

There have been no realized gains or losses on available-for-sale securities for the three and nine months ended September 30, 2020 and 2019.

All marketable securities with unrealized losses at September 30, 2020 have been in a loss position for less than twelve months.

Based on the Company’s application of its expected loss allowance methodology, it is probable that the principal and interest will be collected in accordance with the contractual terms, and that the unrealized loss on these securities were not attributable to credit risk.

Inventory consists of the following (in thousands):

September 30,

Work-in-process

3 unchanged sentences

Accrued liabilities consist of the following (in thousands):

September 30,

Research, clinical study, and manufacturing expenses

2 unchanged sentences

The following table disaggregates total revenues from customers (in thousands):

Three Months Ended June 30,

Six Months Ended June 30,

Three Months Ended

September 30,

Nine Months Ended September 30,

Collaboration and license revenue:

1 unchanged sentence

share territory

Royalty revenue in European territory

Crysvita royalty revenue in European

Daiichi Sankyo

2 unchanged sentences

Total product sales

Non-cash collaboration royalty revenue

Crysvita non-cash collaboration royalty

Total revenues

The following table disaggregates total revenues based on geographic location (in thousands):

Three Months Ended June 30,

Six Months Ended June 30,

United States

Three Months Ended

September 30,

Nine Months Ended September 30,

North America

Total revenues

The following table presents changes in the contract assets (liabilities) (in thousands):

Six Months Ended June 30,

Balance of contract assets (liabilities) at beginning of period

Balance of contract liabilities at end of period

Nine Months Ended September 30,

Balance of contract assets at beginning of period

Balance of contract liabilities at end of period, net

See Note 6 for additional details on contract assets (liabilities) activities.

The Company’s largest accounts receivable balance accounted for 79 % and 87 % of the total accounts receivable balance as of June 30, 2020 and December 31, 2019, respectively, and was due from a collaboration partner.

The Company’s largest accounts receivable balance accounted for 83 % and 87 % of the total accounts receivable balance as of September 30, 2020 and December 31, 2019, respectively, and was due from a collaboration partner.

License and Research Agreements

5 unchanged sentences

In the field of orphan diseases, and except for ongoing studies being conducted by KKC, the Company is the lead party for development activities in the profit-share territory and in the European territory until the applicable transition date;

the Company is also the lead party for core development activities conducted in Japan and Korea, for which the core development plan is limited to clinical trials mutually agreed to by the Company and KKC.

the Company is

also the lead party for core development activities conducted in Japan and Korea, for which the core development plan is limited to clinical trials mutually agreed to by the Company and KKC.

The Company shares the costs for development activities in the profit-share territory and the European territory conducted pursuant to the development plan before the applicable transition date equally with KKC.

16 unchanged sentences

Beginning in 2020, the Company records the royalty revenue as non-cash royalty revenues.

During the three months ended June 30, 2020, there was a change in estimate of the revenue reserves related to sales made prior to January 1, 2020, as a result of which, the Company recorded $ 1.5 million as royalty revenue in European territory.

During the nine months ended September 30, 2020, there was a change in estimate of the revenue reserves related to sales made prior to January 1, 2020, as a result of which, the Company recorded $ 1.5 million as royalty revenue in European territory.

The Company’s share of collaboration and royalty revenue related to Crysvita was as follows (in thousands):

Three Months Ended June 30,

Six Months Ended June 30,

Three Months Ended September 30,

Nine Months Ended September 30,

Company's share of revenue in profit-

6 unchanged sentences

Accordingly, the Company records revenue on a gross basis related to the sale of Crysvita once the product is delivered and the risk and title of the product is transferred to the distributor.

The Company recorded product sales of $ 2.5 million and $ 4.2 million for the three and six months ended June 30, 2020, respectively, and $ 1.0 million and $ 1.6 million for the three and six months ended June 30, 2019, respectively, net of estimated product returns and other deductions.

The Company recorded product sales of $ 3.3 million and $ 7.4 million for the three and nine months ended September 30, 2020, respectively, and $ 1.1 million and $ 2.7 million for the three and nine months ended September 30, 2019, respectively, net of estimated product returns and other deductions.

KKC has the option to assume responsibility for commercialization efforts in Turkey from the Company, after a certain minimum period.

4 unchanged sentences

As a result, the Company was reimbursed for these costs and operating expenses were reduced as follows (in thousands):

Three Months Ended June 30,

Six Months Ended June 30,

Three Months Ended September 30,

Nine Months Ended September 30,

Research and development

1 unchanged sentence

Collaboration receivable

The Company had accounts receivable from KKC in the amount of $ 11.8 million and $ 28.5 million from profit-share revenue and royalties and other receivables recorded in prepaid and other current assets of $ 8.2 million and $ 17.8 million and accrued liabilities of $ 1.3 million and $ 0.9 million from commercial and development activity reimbursements, as of June 30, 2020 and December 31, 2019, respectively.

The Company had accounts receivable from KKC in the amount of $ 23.2 million and $ 28.5 million from profit-share revenue and royalties and other receivables recorded in prepaid and other current assets of $ 12.9 million and $ 17.8 million and accrued liabilities of $ 1.6 million and $ 0.9 million from commercial and development activity reimbursements, as of September 30, 2020 and December 31, 2019, respectively.

Bayer HealthCare LLC

6 unchanged sentences

The Company achieved the first milestone in December 2017, the second milestone in April 2018, and has received $ 15.0 million for such milestones to date.

The Company’s obligations under the contract were completed by end of December 31, 2019 and as a result, no revenue was recorded for the three and six months ended June 30, 2020.

The Company recorded revenue of $ 0.1 million and $ 0.4 million for the three and six months ended June 30, 2019, respectively.

The Company’s obligations under the contract were completed by end of December 31, 2019 and no revenue was recorded for the three and nine months ended September 30, 2020.

The Company recorded revenue of $ 0.1 million and $ 0.5 million for the three and nine months ended September 30, 2019, respectively.

The Company may record future milestone payments as revenue, if it becomes probable that a significant reversal in the amount of revenue recognized will not occur and when the uncertainty associated with the variable consideration is subsequently resolved.

The Company has a Research Collaboration and License Agreement with Arcturus to research and develop therapies for select rare diseases.

Pursuant to the agreement, the Company incurred $ 0.4 million and $ 0.6 million for the three and six months ended June 30, 2019, respectively, in research and development expense for the funding of certain research services received from Arcturus.

Pursuant to the agreement, the Company incurred none and $ 0.7 million for the three and nine months ended September 30, 2019, respectively, in research and development expense for the funding of certain research services received from Arcturus.

No research and development expenses were recognized in 2020 related to the Arcturus agreement.

8 unchanged sentences

Fair value of option to purchase additional shares of Arcturus common stock

Acquisition of investment in Arcturus

securities in June 2019

Acquisition of investment in Arcturus securities

Change in fair value

2 unchanged sentences

Transfer of value upon option exercise

June 30, 2020

September 30, 2020

The Company recorded $ 11.5 million in unrealized loss for the three months ended September 2020 from the fair value adjustment on the investment in Arcturus common stock.

In August 2019, the Company entered into a Program Agreement and a Unitholder Option Agreement with GeneTx Biotherapeutics, LLC (GeneTx) to collaborate on the development of GeneTx’s GTX-102, an antisense oligonucleotide (ASO) for the treatment of Angelman syndrome.

Pursuant to the terms of the Unitholder Option Agreement, the Company made an upfront payment of $ 20.0 million for an exclusive option to acquire GeneTx, which was exercisable any time prior to 30 days following FDA acceptance of the IND for GTX-102.

Pursuant to the agreement, upon acceptance of IND, the Company elected to extend the option period by paying an option extension payment of $ 25.0 million (option extension premium) during the prior quarter ended March 31, 2020.

Pursuant to the agreement, upon acceptance of the IND, which occurred in January 2020, the Company elected to extend the option period by paying an option extension payment of $ 25.0 million (option extension premium) during the prior quarter ended March 31, 2020.

The Company has a right to acquire GeneTx for a payment of $ 125.0 million, at any time, until the earlier of 30 months from the first dosing of a patient in a planned Phase 1/2 study (subject to extensions) or 90 days after results are available from that study.

2 unchanged sentences

The Company will provide support, at its discretion, including strategic guidance and clinical expertise.

The Company and GeneTx will collaborate on the submission of the IND and management of the Phase 1/2 study in patients with Angelman syndrome.

The Company and GeneTx will collaborate on the management of the Phase 1/2 study in patients with Angelman syndrome.

If the Company acquires GeneTx, the Company will then be responsible for all development and commercialization activities from the date of acquisition.

2 unchanged sentences

Prior to product regulatory approval, all consideration paid to GeneTx represents rights to potential future benefits associated with GeneTx’s in-process research and development activities, which have not reached technological feasibility and have no alternative future use.

Accordingly, for the three and six months ended June 30, 2020, the Company recorded the option extension payment of none and $ 25.0 million as an in-process research and development expense.

Accordingly, for the nine months ended September 30, 2020, the Company recorded the option extension payment of $ 25.0 million as an in-process research and development expense.

REGENXBIO, Inc.

16 unchanged sentences

The Company also entered into a Stock Purchase Agreement (SPA) with Daiichi Sankyo, pursuant to which Daiichi Sankyo purchased 1,243,913 shares in exchange for $ 75.0 million in cash during the first quarter of 2020.

The fair market value of the common stock issued to Daiichi Sankyo was $ 55.3 million based on the stock price of $ 44.43 on the date of issuance, resulting in a $ 19.7 million premium on the SPA.

The fair market value of the common stock issued to Daiichi Sankyo was $ 55.3 million based on the stock price of $ 44.43 per share on the date of issuance, resulting in a $ 19.7 million premium on the SPA.

Daiichi Sankyo is also subject to a three-year standstill and restrictions on sale of the shares (subject to customary exceptions or release).

1 unchanged sentence

The License Agreement, the Sublicense Agreement, and the SPA are being accounted for as one arrangement because they were entered into at or near the same time and negotiated in contemplation of one another.

The Company evaluated the License Agreement and the Sublicense Agreement under ASC 606 and determined that the performance obligations under the agreements are (i) intellectual property with respect to its HeLa PCL and HEK293 transient transfection manufacturing technology platforms together with the initial technical assistance and technology transfer services, which are expected to be completed over a period of 18 months, and (ii) the transfer of any know-how and improvements after the completion of the initial technology transfer through the end of the three year technology transfer period.

The Company evaluated the License Agreement and the Sublicense Agreement under ASC 606 and determined that the performance obligations under the agreements are (i) intellectual property with respect to its HeLa PCL and HEK293 transient transfection manufacturing technology platforms together with the initial technical assistance and technology transfer services, which are expected to be completed over a period of 18 to 21 months, and (ii) the transfer of any know-how and improvements after the completion of the initial technology transfer through the end of the three year technology transfer period.

The Company determined that the total transaction price of the License Agreement was $ 183.6 million which was comprised of the $ 19.7 million premium from the SPA, the $ 125.0 million upfront payment, the $ 25.0 million in unconstrained milestone payments, $ 8.0 million from the Sublicense Agreement, and the $ 5.9 million estimated reimbursement amount for delivering the license and technology services.

5 unchanged sentences

Royalties from commercial sales will be accounted for as revenue upon achievement of such sales, assuming all other revenue recognition criteria are met.

The technology transfer services were initiated during the second quarter of 2020, as such the Company began recognizing revenue during the period.

For the three and six months ended June 30, 2020, the Company recognized $ 18.9 million in revenue related to this arrangement.

Accordingly, the Company had recorded $ 131.6 million as short-term contract liability and $ 3.3 million as long- term contract liability as of June 30, 2020.

The Company had a receivable related to the above agreements of $ 8.5 million as of June 30, 2020.

For the three and nine months ended September 30, 2020, the Company recognized $ 32.9 million and $ 51.7 million, respectively, in revenue related to this arrangement.

Accordingly, the Company had recorded $ 102.9 million as contract liabilities, net, as of September 30, 2020.

The Company recorded a receivable related to the above agreements of $ 0.9 million as of September 30, 2020 in prepaid expenses and other current assets.

Liability Related to the Sale of Future Royalties

10 unchanged sentences

To the extent such payments are greater or less than the Company’s initial estimates or the timing of such payments is materially different than its original estimates, the Company will prospectively adjust the amortization of the liability and the effective interest rate.

The Company’s effective annual interest rate was approximately 10.3 % and 10.1 % as of June 30, 2020 and December 31, 2019, respectively.

The Company’s effective annual interest rate was approximately 10.3 % and 10.1 % as of September 30, 2020 and December 31, 2019, respectively.

There are a number of factors that could materially affect the amount and timing of royalty payments from KKC in the applicable European territories, most of which are not within the Company’s control.

Such factors include, but are not limited to, the success of KKC’s sales and promotion of Crysvita, changing standards of care, delays or disruptions related to the COVID-19 pandemic, the introduction of competing products, approval of label expansion for adults, pricing for reimbursement in various European territories, manufacturing or other delays, intellectual property matters, adverse events that result in governmental health authority imposed restrictions on the use of Crysvita, significant changes in foreign exchange rates as the royalty payments are made in U.S.

Such factors include, but are not limited to, the

success of KKC’s sales and promotion of Crysvita, changing standards of care, delays or disruptions related to the COVID-19 pandemic, the introduction of competing products, pricing for reimbursement in various European territories, manufacturing or other delays, intellectual property matters, adverse events that result in governmental health authority imposed restrictions on the use of Crysvita, significant changes in foreign exchange rates as the royalty payments are made in U.S.

dollars (USD) while significant portions of the underlying European sales of Crysvita are made in currencies other than USD, and other events or circumstances that could result in reduced royalty payments from European sales of Crysvita, all of which would result in a reduction of non-cash royalty revenue and the non-cash interest expense over the life of the arrangement.

2 unchanged sentences

Liability related to the sale of future royalties

Proceeds from sale of future royalties in December 2019

Proceeds from sale of future royalties in

December 2019

Non-cash interest expense

2 unchanged sentences

Non-cash interest expense

June 30, 2020

September 30, 2020

Stock-Based Awards

The 2014 Incentive Plan (the 2014 Plan) provides for automatic annual increases in shares available for grant, beginning on January 1, 2015 through January 1, 2024 .

As of June 30, 2020 , there were 3,304,531 shares reserved under the 2014 Plan for the future issuance of equity awards and 3,287,825 shares reserved for the 2014 Employee Stock Purchase Plan.

As of September 30, 2020 , there were 3,186,920 shares reserved under the 2014 Plan for the future issuance of equity awards and 3,287,825 shares reserved for the 2014 Employee Stock Purchase Plan.

The table below sets forth the stock-based compensation expense for the periods presented (in thousands):

Three Months Ended June 30,

Six Months Ended June 30,

Three Months Ended

September 30,

Nine Months Ended

September 30,

Cost of sales

2 unchanged sentences

Total stock-based compensation expense

Net Income (Loss) Per Share

Basic net income (loss) per share has been computed by dividing the net income (loss) by the weighted-average number of shares of common stock outstanding during the period.

Diluted net income (loss) per share is calculated by dividing net income (loss) by the weighted-average number of shares of common stock and potential dilutive securities outstanding during the period.

For the six months ended June 30, 2020 and the three and six months ended June 30, 2019, there were no differences between basic and diluted net loss per share since the effect of the dilutive securities would have been antidilutive and therefore were excluded from the diluted net loss per share calculation.

The following table sets forth the computation of the basic and diluted net income (loss) per share (in thousands, except share and per share data):

Three Months Ended June 30,

Six Months Ended June 30,

Net income (loss), basic and diluted

Weighted-average shares used in computing net income

(loss) per share, basic

Weighted-average effect of dilutive securities:

Options to purchase common stock and RSUs

Weighted-average shares used in computing net income

(loss) per share, diluted

Net income (loss) per share:

The following weighted-average outstanding common stock equivalents were excluded from the computation of diluted net income (loss) per share for the periods presented because including them would have been antidilutive:

Three Months Ended June 30,

Six Months Ended June 30,

Net Loss Per Share

Basic net loss per share has been computed by dividing the net loss by the weighted-average number of shares of common stock outstanding during the period.

Diluted net loss per share is calculated by dividing net loss by the weighted-average number of shares of common stock and potential dilutive securities outstanding during the period.

The following weighted-average outstanding common stock equivalents were excluded from the computation of diluted net loss per share for the periods presented because including them would have been antidilutive:

Three Months Ended

September 30,

Nine Months Ended

September 30,

Options to purchase common stock and

4 unchanged sentences

In July 2017, the Company entered into an At-The-Market, or ATM, sales agreement with Cowen and Company, LLC (Cowen), whereby the Company could sell up to $ 150.0 million in aggregate proceeds of common stock from time to time, with Cowen as its sales agent.

During the three and six months ended June 30, 2020, the Company sold 283,333 shares of common stock, resulting in net proceeds of $ 20.4 million, after commissions and other offering costs.

During the three and six months ended June 30, 2019, the Company sold 88,978 and 468,685 shares of common stock, respectively, resulting in net proceeds of approximately $ 5.5 million and $ 24.8 million, respectively, after commissions and other offering costs.

As of June 30, 2020 , the Company had completed the sale of all available amounts under the ATM facility.

During the three months ended June 30, 2020, the Company sold 283,333 shares of common stock, resulting in net proceeds of $ 20.4 million, after commissions and other offering costs.

As of June 30, 2020, the Company had completed the sale of all

available amounts under the ATM facility.

During the three and nine months ended September 30, 2019, the Company sold none and 468,685 shares of common stock, respectively, resulting in net proceeds of approximately none and $ 24.8 million, respectively, after commissions and other offering costs.

In February 2019, the Company completed an underwritten public offering in which 5,833,333 shares of common stock were sold, which included 760,869 shares purchased by the underwriters pursuant to an option granted to them in connection with the offering, at a public offering price of $ 60.00 per share.

2 unchanged sentences

Total accumulated other comprehensive income (loss) consisted of the following (in thousands):

September 30,

Foreign currency translation adjustments

Unrealized gain on securities available-for-sale

Unrealized gain on available-for-sale securities

Total accumulated other comprehensive income

Subsequent Event

On October 23, 2020, the Company announced that it had entered into a strategic collaboration and license agreement (the collaboration agreement) with Solid Biosciences, Inc.

(Solid) to focus on the development and commercialization of new gene therapies for Duchenne muscular dystrophy (Duchenne) using its HeLa producer cell line (PCL) manufacturing platform.

Under the terms of the collaboration agreement, Solid granted the Company an exclusive license for any pharmaceutical product that expresses Solid’s proprietary microdystrophin construct from AAV8 and variants thereof in clade E for use in the treatment of Duchenne and other diseases resulting from lack of functional dystrophin.

The Company also entered into a stock purchase agreement and investor agreement with Solid in connection with the collaboration agreement, and purchased 7,825,797 shares of Solid’s common stock for an aggregate purchase price of $ 40.0 million.

The Company will pay Solid up to $ 255.0 million in cumulative milestone payments per product upon achievement of specified milestone events, and tiered royalties on worldwide net sales at low double-digit to mid-teens percentages.

Upon achievement of proof-of-concept, Solid has the right to opt-in to co-fund collaboration programs in return for participation in a profit share or increased royalty payments.

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-Q

Item 1. Financial Statements