true000108203800010820382024-11-222024-11-22

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

Form 8-K/A

 

Current Report

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

November 22, 2024

Date of Report

(Date of earliest event reported)

 

DURECT CORPORATION

(Exact name of Registrant as specified in its charter)

 

Delaware

 

000-31615

 

94-3297098

(State or other jurisdiction of

incorporation or organization)

 

(Commission

File Number)

 

(I.R.S. Employer

Identification No.)

10240 Bubb Road

Cupertino, CA 95014

(Address of principal executive offices) (Zip code)

(408) 777-1417

(Registrant’s telephone number, including area code)

(Former name or former address, if changed since last report)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

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

 

Title of Each Class

Trading Symbol

Name of Each Exchange on Which Registered

Common Stock $0.0001 par value per share

Preferred Share Purchase Rights

 

DRRX

The NASDAQ Stock Market LLC

(The Nasdaq Capital Market)

 

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).

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.

 

 


 

EXPLANATORY NOTE

On November 25, 2024, DURECT Corporation (the “Company”) filed with the Securities and Exchange Commission a Current Report on Form 8-K (the “Initial 8-K”) to disclose that it had completed its sale of ALZET Product Line to Lafayette Instruments Co. (the “Transaction”). This Form 8-K/A amends the Initial 8-K to include the pro forma financial information of the Company giving effect to the completion of the Transaction required by Item 9.01(b) of Form 8-K.

Item 9.01 Financial Statements and Exhibits

(b) Pro Forma Financial Information.

The following unaudited pro forma condensed financial information of the Company, giving effect to the Transaction, is attached hereto as Exhibit 99.1 and is incorporated herein by reference:

Unaudited Pro Forma Condensed Balance Sheet as of September 30, 2024;
Unaudited Pro Forma Condensed Statement of Operations and Comprehensive Loss for the Nine Months Ended September 30, 2024; and
Unaudited Pro Forma Condensed Statement of Operations and Comprehensive Loss for the Year Ended December 31, 2023.

 

(d) Exhibits

 

99.1

Unaudited Pro Forma Condensed Financial Information of the Company

 

104

Cover Page Interactive Data File (embedded within the Inline XBRL document)

 

2


 

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

 

 

DURECT Corporation

 

 

 

 

 

Date: November 29, 2024

 

By:

 

/s/ James E. Brown

 

 

 

 

    James E. Brown

    President and Chief Executive Officer

 

 

 

 

 

 

3


Exhibit 99.1

 

UNAUDITED PRO FORMA CONDENSED FINANCIAL INFORMATION

On November 22, 2024 (the “Closing Date”), DURECT Corporation (the “Company”) completed the sale (the “Transaction”) to Alzet, LLC, a subsidiary of Lafayette Instrument Co. (the “Purchaser”), of substantially all the assets and certain specified liabilities related to the ALZET product line (the “Sale”) pursuant to the Asset Purchase Agreement (the “APA”) between the Company and the Purchaser. Pursuant to the terms of the APA, the Purchaser paid the Company $17.5 million subject to certain adjustments, including for net working capital. Also on the Closing Date, the Company and the Purchaser entered into a Transition Services Agreement, pursuant to which the Company agrees to perform certain transition services related to the purchased assets for up to six months after the Closing Date, subject to potential extensions. The estimated total transaction expenses were approximately $2.2 million.

Simultaneous with this transaction, the Company has paid off all remaining obligations under its term loan agreement with Oxford Finance LLC. The total payment to Oxford Finance LLC was $9.2 million, which included a principal payment of $7.1 million, a final payment of $2.0 million, and accrued interest and prepayment penalty totaling $106,000.

The following unaudited pro forma condensed financial statements are intended to show how the Transaction might have affected the historical financial statements of DURECT if the Transaction had been completed at an earlier time as indicated therein, and such unaudited pro forma condensed financial statements are derived from, and should be read in conjunction with, DURECT’s historical financial statements and notes thereto, as presented in its Quarterly Report on Form 10-Q for the nine months ended September 30, 2024 and Annual Report on Form 10-K for the year ended December 31, 2023, respectively. The unaudited pro forma condensed financial information has been prepared in accordance with Article 11 of Regulation S-X, as amended. The unaudited pro forma condensed balance sheet as of September 30, 2024 assumes the Transaction had occurred on September 30, 2024. The unaudited pro forma condensed statements of operations and comprehensive loss for the nine months ended September 30, 2024 gives effect to the Transaction as if it had occurred as of January 1, 2023 and the Company had paid off all remaining obligations under the term loan agreement with Oxford Finance LLC as of January 1, 2023. The unaudited pro forma condensed statements of operations and comprehensive loss for the year ended December 31, 2023 gives effect to the Transaction as if it had occurred as of January 1, 2023 and the Company had paid off all remaining obligations under the term loan agreement with Oxford Finance LLC as of January 1, 2023. The Company’s accounting and financial reporting in these unaudited pro forma condensed financial statements is based on its preliminary assessment of the appropriate application of U.S. GAAP. The final application of U.S. GAAP to the APA may differ from what is presented in these unaudited pro forma condensed financial statements.

The transaction accounting adjustments to reflect the sale of the ALZET product line in the unaudited pro forma condensed financial statements include:

the Sale and the derecognition of associated assets and liabilities pursuant to the APA;
adjustments required to record the estimated cash proceeds received in connection with the Transaction;

 

adjustments required to recognize the transaction costs arising from the Transaction;

 

adjustments required to recognize the estimated gain associated with the Transaction;

 

adjustments required to derecognize ALZET associated revenues and expenses; and

 

the use of proceeds received from the Transaction and existing cash and investments to repay the remainder of a term loan.

The unaudited pro forma condensed financial statements are presented for informational purposes only and are based upon estimates by DURECT’s management, which are based upon available information and certain assumptions that DURECT’s management believes are reasonable as of the date of this filing. Actual amounts could differ materially from these estimates. The unaudited pro forma condensed financial statements are not intended to be indicative of the actual financial position or results of operations that would have been achieved had the Transaction been consummated as of the periods indicated above, nor do they purport to indicate results which may be attained in the future. For example, these financial statements do not


reflect any potential earnings or other impacts from the use of the proceeds from the sale or any synergies and dis-synergies that could result from the sale.

 

The unaudited pro forma condensed balance sheet as of September 30, 2024, and the unaudited pro forma condensed statements of operations and comprehensive loss for the nine months ended September 30, 2024 and the year ended December 31, 2023, should be read in conjunction with the notes thereto.


DURECT CORPORATION

PRO FORMA CONDENSED BALANCE SHEETS

AS OF SEPTEMBER 30, 2024

(in thousands)

(unaudited)

 

 

 

Historical

 

 

 

 

 

Pro Forma

 

 

 

As of

 

 

Transaction

 

 

As of

 

 

 

September 30,

 

 

Accounting

 

 

September 30,

 

 

 

2024

 

 

Adjustments

 

 

2024

 

A S S E T S

 

 

 

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

9,086

 

 

$

4,613

 

(a), (b)

$

13,699

 

Short-term investments

 

 

1,290

 

 

 

 

 

 

1,290

 

Accounts receivable, net

 

 

1,016

 

 

 

(578

)

(a)

 

438

 

Inventories, net

 

 

2,376

 

 

 

(2,250

)

(a)

 

126

 

Prepaid expenses and other current assets

 

 

657

 

 

 

21

 

(a), (b)

 

678

 

Total current assets

 

 

14,425

 

 

 

1,806

 

 

 

16,231

 

Property and equipment, net

 

 

52

 

 

 

(1

)

(a)

 

51

 

Operating lease right-of-use assets

 

 

3,142

 

 

 

(790

)

(a)

 

2,352

 

Goodwill

 

 

6,169

 

 

 

(3,444

)

(a)

 

2,725

 

Long-term restricted investments

 

 

150

 

 

 

 

 

 

150

 

Other long-term assets

 

 

128

 

 

 

(5

)

(a)

 

123

 

Total assets

 

$

24,066

 

 

$

(2,434

)

 

$

21,632

 

L I A B I L I T I E S A N D S T O C K H O L D E R S’ E Q U I T Y

 

 

 

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

 

 

 

Accounts payable

 

$

498

 

 

$

(58

)

(a)

$

440

 

Accrued liabilities

 

 

4,798

 

 

 

(362

)

(a)

 

4,436

 

Term loan, current portion, net

 

 

10,466

 

 

 

(10,466

)

(a)

 

 

Operating lease liabilities, current portion

 

 

1,308

 

 

 

(235

)

(a)

 

1,073

 

Warrant liabilities

 

 

3,137

 

 

 

 

 

 

3,137

 

Total current liabilities

 

 

20,207

 

 

 

(11,121

)

 

 

9,086

 

Operating lease liabilities, non-current portion

 

 

1,966

 

 

 

(621

)

(a)

 

1,345

 

Other long-term liabilities

 

 

676

 

 

 

(50

)

(a)

 

626

 

Commitments and contingencies

 

 

 

 

 

 

 

 

 

Stockholders’ equity:

 

 

 

 

 

 

 

 

 

Common stock

 

 

23

 

 

 

 

 

 

23

 

Additional paid-in capital

 

 

605,828

 

 

 

 

 

 

605,828

 

Accumulated deficit

 

 

(604,634

)

 

 

9,358

 

(c), (f)

 

(595,276

)

Stockholders’ equity

 

 

1,217

 

 

 

9,358

 

 

 

10,575

 

Total liabilities and stockholders’ equity

 

$

24,066

 

 

$

(2,434

)

 

$

21,632

 

 

See accompanying notes to the unaudited pro forma condensed financial information.

 

 

 

 

 

 

 

 

 


DURECT CORPORATION

PRO FORMA CONDENSED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

FOR THE NINE MONTHS ENDED SEPTEMBER 30, 2024

(in thousands, except per share amounts)

(Unaudited)

 

 

 

Nine months ended
September 30, 2024

 

 

 

Historical

 

 

Transaction

Pro Forma

 

 

 

 

 

 

Accounting

 

 

 

 

 

 

 

Adjustments

 

 

Collaborative research and development and other revenue

 

$

1,471

 

 

$

 

 

$

1,471

 

Product revenues, net

 

 

4,454

 

 

 

(4,347

)

(d)

 

107

 

Total revenues

 

 

5,925

 

 

 

(4,347

)

 

 

1,578

 

Operating expenses:

 

 

 

 

 

 

 

 

 

Cost of product revenues

 

 

1,158

 

 

 

(1,101

)

(e)

 

57

 

Research and development

 

 

8,530

 

 

 

 

 

 

8,530

 

Selling, general and administrative

 

 

9,325

 

 

 

(1,059

)

(e), (f)

 

8,266

 

Total operating expenses

 

 

19,013

 

 

 

(2,160

)

 

 

16,853

 

Loss from operations

 

 

(13,088

)

 

 

(2,187

)

 

 

(15,275

)

 

 

 

 

 

 

 

 

 

 

Other income (expense):

 

 

 

 

 

 

 

 

 

Interest and other income

 

 

711

 

 

 

 

 

 

711

 

Interest and other expenses

 

 

(1,338

)

 

 

1,338

 

 (i)

 

 

Change in fair value of warrant liabilities

 

 

(1,913

)

 

 

 

 

 

(1,913

)

Other income (expense), net

 

 

(2,540

)

 

 

1,338

 

 

 

(1,202

)

Net loss

 

 

(15,628

)

 

 

(849

)

 

 

(16,477

)

Net change in unrealized gain on available-for-sale securities, net of reclassification adjustments and taxes

 

 

14

 

 

 

 

 

 

14

 

Total comprehensive loss

 

$

(15,614

)

 

$

(849

)

 

$

(16,463

)

 

 

 

 

 

 

 

 

 

 

Net loss per share

 

 

 

 

 

 

 

 

 

Basic

 

$

(0.51

)

 

 

 

 

$

(0.53

)

Diluted

 

$

(0.51

)

 

 

 

 

$

(0.53

)

 

 

 

 

 

 

 

 

 

 

Weighted-average shares used in computing net loss per share

 

 

 

 

 

 

 

 

 

Basic

 

 

30,906

 

 

 

 

 

 

30,906

 

Diluted

 

 

30,906

 

 

 

 

 

 

30,906

 

 

See accompanying notes to the unaudited pro forma condensed financial information.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 


DURECT CORPORATION

PRO FORMA CONDENSED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

FOR THE YEAR ENDED DECEMBER 31, 2023

(in thousands, except per share amounts)

(Unaudited)

 

 

 

Twelve months ended
December 31, 2023

 

 

 

Historical

 

 

Transaction

Pro Forma

 

 

 

 

 

 

Accounting

 

 

 

 

 

 

 

Adjustments

 

 

Collaborative research and development and other revenue

 

$

2,277

 

 

$

 

 

$

2,277

 

Product revenues, net

 

 

6,271

 

 

 

(5,958

)

(d)

 

313

 

Total revenues

 

 

8,548

 

 

 

(5,958

)

 

 

2,590

 

Operating expenses:

 

 

 

 

 

 

 

 

 

Cost of product revenues

 

 

1,717

 

 

 

(1,449

)

(e)

 

268

 

Research and development

 

 

29,351

 

 

 

 

 

 

29,351

 

Selling, general and administrative

 

 

14,364

 

 

 

463

 

(e), (f)

 

14,827

 

Total operating expenses

 

 

45,432

 

 

 

(986

)

 

 

44,446

 

Loss from operations

 

 

(36,884

)

 

 

(4,972

)

 

 

(41,856

)

 

 

 

 

 

 

 

 

 

 

Gain on sale of the ALZET product line

 

 

 

 

 

11,476

 

(g)

 

11,476

 

 

 

 

 

 

 

 

 

 

 

Other income (expense):

 

 

 

 

 

 

 

 

 

Interest and other income

 

 

2,129

 

 

 

(388

)

 (h)

 

1,741

 

Interest and other expenses

 

 

(2,792

)

 

 

2,792

 

 (i)

 

 

Loss on debt extinguishment

 

 

 

 

 

(1,130

)

 (j)

 

(1,130

)

Change in fair value of warrant liabilities

 

 

13,583

 

 

 

 

 

 

13,583

 

Issuance cost for warrants

 

 

(1,627

)

 

 

 

 

 

(1,627

)

Loss on issuance of warrants

 

 

(2,033

)

 

 

 

 

 

(2,033

)

Other income (expense), net

 

 

9,260

 

 

 

1,274

 

 

 

10,534

 

Net loss

 

 

(27,624

)

 

 

7,778

 

 

 

(19,846

)

Net change in unrealized loss on available-for-sale securities, net of reclassification adjustments and taxes

 

 

(1

)

 

 

 

 

 

(1

)

Total comprehensive loss

 

$

(27,625

)

 

$

7,778

 

 

$

(19,847

)

 

 

 

 

 

 

 

 

 

 

Net loss per share

 

 

 

 

 

 

 

 

 

Basic

 

$

(1.05

)

 

 

 

 

$

(0.76

)

Diluted

 

$

(1.20

)

 

 

 

 

$

(0.91

)

 

 

 

 

 

 

 

 

 

 

Weighted-average shares used in computing net loss per share

 

 

 

 

 

 

 

 

 

Basic

 

 

26,256

 

 

 

 

 

 

26,256

 

Diluted

 

 

26,520

 

 

 

 

 

 

26,520

 

 

See accompanying notes to the unaudited pro forma condensed financial information.

 

 

 

 

 

 


Notes to Pro Forma Condensed Financial Statements

Note 1 — Basis of Presentation

The pro forma financial information is prepared pursuant to Article 11 of Regulation S-X. The pro forma adjustments are described in the accompanying notes and are based upon and derived from information and assumptions available at the time of the filing of the Current Report on Form 8-K/A to which this pro forma financial information is attached.

The pro forma financial information is based on financial statements prepared in accordance with U.S. GAAP, which is subject to change and interpretation. The pro forma financial information is based on and derived from the Company’s historical condensed financial statements, adjusted for certain transaction accounting adjustments. Actual adjustments, however, may differ materially from the information presented. The pro forma adjustments do not include allocations of corporate costs, as those are not directly attributable to the Transaction. The pro forma adjustments also do not include management adjustments to reflect any potential dis-synergy costs or benefits that may result from the realization of future cost savings in connection with the Transaction as management does not believe presenting such adjustments would enhance an understanding of the pro forma effects thereof. In addition, the pro forma financial information is based upon available information and assumptions that management considers to be reasonable, and such assumptions have been made solely for purposes of developing such pro forma financial information for illustrative purposes in compliance with the disclosure requirements of the U.S Securities and Exchange Commission. The unaudited pro forma condensed financial information is not necessarily indicative of what the financial position or results of operations would have actually been had the Transaction occurred on the dates indicated. The unaudited pro forma condensed financial information does not include any compensation related to the transition services agreement as compensation related to this agreement cannot be reasonably estimated. In addition, the pro forma financial information should not be considered to be indicative of the Company’s future financial performance and results of operations.

Note 2 — Pro Forma Adjustments

The unaudited pro forma condensed financial statements reflect the following notes and adjustments:

(a)
The Sale and derecognition of the associated assets and liabilities pursuant to the APA.
(b)
Recognition of $17.5 million of cash received for the Sale, $10.7 million of cash paid to Oxford Finance to pay the remaining obligation of the term loan (based on the outstanding principal balance as of September 30, 2024) and $2.2 million of cash paid for transaction expenses of $2.1 million and escrow amount of $150,000 at the closing of the Transaction as of September 30, 2024.
(c)
Recognition of a $11.5 million gain on the Transaction allocated to DURECT, assuming the Transaction had occurred on September 30, 2024.
(d)
Derecognition of ALZET associated revenues for the year ended December 31, 2023, and the nine months ended September 30, 2024.
(e)
Derecognition of ALZET associated expenses for the year ended December 31, 2023, and the nine months ended September 30, 2024.
(f)
Recognition of transaction expenses incurred as a result of the Transaction not yet reflected in the results of operations, in the amount of $2.0 million. The statement of operations and comprehensive loss for the nine months ended September 30, 2024 includes transaction expenses incurred of $0.2 million.
(g)
Recognition of a $11.5 million gain on the Transaction, assuming the Transaction had occurred on January 1, 2023.

(h)
Reduction of interest income associated with additional cash and investments (in excess of the net proceeds from the Transaction after deducting the transaction costs) used to pay the remainder of a term loan for the year ended December 31, 2023.

 

(i)
Derecognition of term loan interest associated expenses for the year ended December 31, 2023, and the nine months ended September 30, 2024.

 

(j)
Recognition of loss on debt extinguishments for the year ended December 31, 2023.

v3.24.3
Document and Entity Information
Nov. 22, 2024
Cover [Abstract]  
Document Type 8-K/A
Amendment Flag true
Amendment Description This Form 8-K/A amends the Initial 8-K to include the pro forma financial information of the Company giving effect to the completion of the Transaction required by Item 9.01(b) of Form 8-K
Document Period End Date Nov. 22, 2024
Title of 12(b) Security Common Stock $0.0001 par value per sharePreferred Share Purchase Rights
Security Exchange Name NASDAQ
Trading Symbol DRRX
Entity Registrant Name DURECT CORP
Entity Central Index Key 0001082038
Entity Emerging Growth Company false
Entity File Number 000-31615
Entity Incorporation, State or Country Code DE
Entity Tax Identification Number 94-3297098
Entity Address, Address Line One 10240 Bubb Road
Entity Address, City or Town Cupertino
Entity Address, State or Province CA
Entity Address, Postal Zip Code 95014
City Area Code 408
Local Phone Number 777-1417
Written Communications false
Soliciting Material false
Pre-commencement Tender Offer false
Pre-commencement Issuer Tender Offer false

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