8-K

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

 

 

FORM 8-K

 

 

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): August 6, 2019

 

 

Akcea Therapeutics, Inc.

(Exact name of Registrant as Specified in Its Charter)

 

 

 

Delaware   001-38137   47-2608175

(State or Other Jurisdiction

of Incorporation)

 

(Commission

File Number)

 

(IRS Employer

Identification No.)

22 Boston Wharf Road

9th Floor

Boston, MA

  02210
(Address of Principal Executive Offices)   (Zip Code)

Registrant’s Telephone Number, Including Area Code: (617) 207-0202

Not Applicable

(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 (see General Instructions A.2. below):

 

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(s)

 

Name of each exchange

on which registered

Common stock   AKCA   NASDAQ

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.  ☐

 

 

 


Item 2.02 Results of Operations and Financial Condition.

On August 6, 2019, Akcea Therapeutics, Inc. (the “Company”) issued a press release announcing the Company’s financial results for the quarter ended June 30, 2019. In addition to disclosing results that are determined in accordance with Generally Accepted Accounting Principles (GAAP), the Company also discloses non-GAAP results of operations, which are adjusted from GAAP to exclude non-cash compensation related to stock awards. The Company is presenting non-GAAP information excluding non-cash compensation related to stock awards because the Company believes it is useful for investors in assessing the Company’s operating results. A copy of the release is furnished with this report as an exhibit pursuant to “Item 2.02. Results of Operations and Financial Condition” of Form 8-K in accordance with SEC Release Nos. 33-8216 and 34-47583.

The information in this Current Report on Form 8-K and the Exhibit attached hereto shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 (the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933 or the Exchange Act, regardless of any general incorporation language in such filing.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits.

 

Exhibit

Number

  

Description

99.1    Press Release dated August 6, 2019


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 thereunto duly authorized.

 

    AKCEA THERAPEUTICS, INC.
Date: August 6, 2019     By:  

/s/ Paula Soteropoulos

      Paula Soteropoulos
      Chief Executive Officer
EX-99.1

Exhibit 99.1

 

LOGO

Akcea Reports Financial Results and Highlights for Second Quarter 2019

Achieved Second Quarter 2019 TEGSEDI® (inotersen) Global Net Product Revenues of $10 Million

Conference Call Webcast Tuesday, August 6, 4:30 p.m. ET at www.akceatx.com

Boston, Mass., August 6th, 2019 (GLOBE NEWSWIRE) — Akcea Therapeutics, Inc. (NASDAQ: AKCA), an affiliate of Ionis Pharmaceuticals, Inc., focused on developing and commercializing drugs to treat patients with serious and rare diseases, today reported financial results for the second quarter ended June 30, 2019. The company reported a net loss for the three and six months ended June 30, 2019 on a GAAP basis of $37 million and $10 million, respectively. On a non-GAAP basis, the company reported a net loss of $23 million for the three months ended June 30, 2019 and reported net income of $23 million for the six months ended June 30, 2019. Akcea had $296 million of cash, cash equivalents and short-term investments as of June 30, 2019.

“We continue to see momentum building in the launch of TEGSEDI and growth in the number of patients diagnosed with hATTR and symptoms of polyneuropathy. This is also a pivotal time for the FCS community as we prepare for the commercial launch of WAYLIVRA in the E.U., the only therapy approved for those with FCS,” said Paula Soteropoulos, Chief Executive Officer of Akcea. “The rest of our pipeline is also progressing. We are on track for two Phase 3 initiations by the end of this year for AKCEA-APO(a)-LRx with Novartis and AKCEA-TTR-LRx with Ionis, and two Phase 2 data readouts from AKCEA-ANGPTL3-LRx and AKCEA-APOCIII-LRx in early 2020. We remain focused on delivering innovative solutions that improve the lives of those affected by serious and rare diseases.”

“We reported product sales of $10 million from the ongoing multi-country launch of TEGSEDI in the second quarter. With $296 million in cash, cash equivalents, and short-term investments, growing revenue from TEGSEDI and future revenue potential from WAYLIVRA in the E.U., we are in a strong financial position to fund the progression of our current operations into 2021. We are uniquely positioned with two products on the market, as well as a pipeline of drugs for both broad and rare diseases that represent meaningful economic opportunities for the company,” said Mike MacLean, Chief Financial Officer of Akcea.

Upcoming Events

 

   

Launch WAYLIVRA in Germany to treat patients with genetically confirmed Familial Chylomicronemia Syndrome, or FCS

 

   

Launch of TEGSEDI in additional E.U. countries and in Latin America through PTC Therapeutics

 

   

Launch of WAYLIVRA in additional E.U. countries

 

   

Report top line results from the Phase 1/2 AKCEA-TTR-LRx study in 2H 2019

 

   

Initiate AKCEA-TTR-LRx Phase 3 program in 2H 2019

 

   

Novartis to initiate Phase 3 trial for AKCEA-APO(a)-LRx


   

Report top line results from Phase 2 studies of AKCEA-ANGPTL3-LRx and AKCEA-APOCIII-LRx in 1H 2020

Recent Events

 

   

Launched TEGSEDI in the U.S., Germany and Canada to treat patients with polyneuropathy of hATTR amyloidosis

 

   

Received final Highly Specialized Technologies (HST) Guidance for TEGSEDI from the National Institute for Health and Care Excellence (NICE), now being implemented by the National Health System in England

 

   

Announced expanded partnership with Ambry Genetics on the hATTR Compass program, a genetic testing program that enables diagnosis and treatment for Hereditary ATTR Amyloidosis (hATTR)

 

   

Received conditional marketing authorization following a positive CHMP opinion for WAYLIVRA in the E.U., earning a $6M milestone payment from PTC Therapeutics

 

   

Reported top line results from the BROADEN study of WAYLIVRA in familial partial lipodystrophy, or FPL, which met the primary endpoint and a key secondary endpoint

 

   

Licensed AKCEA-APO(a)-LRx to Novartis resulting in a $150 million license fee to Akcea split equally with Ionis

 

   

Completed enrollment in the Phase 2 studies of AKCEA-ANGPTL3-LRx and AKCEA-APOCIII-LRx

Financial Results

All non-GAAP amounts referred to in this press release exclude non-cash compensation expense related to equity awards. Please refer to the reconciliation of non-GAAP and GAAP measures, which is provided later in this release.

Revenue

Akcea’s total revenue for the three and six months ended June 30, 2019 was $27 million and $190 million, respectively, which was comprised of product revenue, licensing revenue, and research and development and license revenue. Revenue from sales of TEGSEDI in the three and six months ended June 30, 2019 was $10 million and $17 million, respectively. Licensing revenue for the three and six months ended June 30, 2019 was $6 million. Licensing revenue was recognized upon regulatory approval for WAYLIVRA from the European Commission pursuant to our license agreement with PTC Therapeutics. Akcea’s research and development and license revenue for the three and six months ended June 30, 2019 was $11 million and $168 million, respectively. Research and development and license revenue was primarily related to the $150 million license fee the company earned as a result of Novartis’ exercise of its option to license AKCEA-APO(a)-LRx. Additionally, Akcea recognized research and development revenue related to the amortization of the upfront payment the company received upon the initiation of the collaboration agreement.

Expenses

Akcea’s operating expenses, inclusive of the reimbursement due from Ionis through the companies’ profit/loss share arrangement, for the three and six months ended June 30, 2019 on a GAAP basis were $65 million and $203 million, respectively, and on a non-GAAP basis were $51 million and $170 million, respectively. These amounts compare to GAAP operating expenses of $82 million and $129 million and non-GAAP operating expenses of $70 million and $111 million for the same periods in 2018. The decrease in operating expenses for the three months ended June 30, 2019


compared to the same period in 2018 was primarily due to the completion of clinical activities related to the end of phase 2 meeting for AKCEA-APO(a)-LRx, and a decrease in development activities related to TEGSEDI and WAYLIVRA. The increase in operating expenses for the six months ended June 30, 2019 compared to the same period in the prior year is primarily due to the one-time $75 million sublicense fee paid to Ionis as a result of Novartis exercising its option to license and higher development costs for AKCEA-TTR-LRx and AKCEA-ANGPTL3-LRx.

Net Loss

Akcea reported net loss of $37 million and $10 million on a GAAP basis for the three and six months ended June 30, 2019, compared to a net loss of $62 million and $92 million for the same periods in 2018. Akcea reported non-GAAP net loss of $23 million for the three months ended June 30, 2019, compared to a non-GAAP net loss of $50 million for the same period in 2018. Akcea reported non-GAAP net income of $23 million for the six months ended June 30, 2019, compared to a non-GAAP net loss of $73 million for the same period in 2018. This increase in non-GAAP net income was primarily due to the $150 million license fee the company earned as a result of Novartis’ exercise of its option to license AKCEA-APO(a)-LRx and commercial product revenue which was partially offset by the sublicense fee to Ionis of $75 million and increased operating expenses related to commercialization costs for TEGSEDI and WAYLIVRA.

For the three and six months ended June 30, 2019, basic and diluted net loss per share of common stock owned by Ionis was $0.40 and $0.06, respectively. For the three and six months ended June 30, 2019, basic and diluted net loss per share of common stock owned by others was $0.40 and $0.26, respectively. For the three and six months ended June 30, 2018, basic and diluted net loss per share of common stock owned by Ionis was $0.72 and $1.19, respectively. For the three and six months ended June 30, 2018, basic and diluted net loss per share of common stock owned by others was $0.85 and $1.33, respectively.

Balance Sheet

As of June 30, 2019, Akcea had cash, cash equivalents and short-term investments of $296 million compared to $253 million at December 31, 2018, which the Company believes is sufficient to fund global commercial efforts and to fund progression of Akcea’s current pipeline to decision events.

Conference Call

At 4:30 p.m. Eastern Time today, August 6, 2019, Akcea will conduct a live webcast conference call to discuss this earnings release and related activities. Interested parties may listen to the call by dialing (855) 237-2439, passcode 5993687 or access the webcast at www.akceatx.com. A webcast replay will be available for a limited time at the same address.

ABOUT AKCEA THERAPEUTICS

Akcea Therapeutics, Inc., an affiliate of Ionis Pharmaceuticals, Inc. (NASDAQ: IONS), is a biopharmaceutical company focused on developing and commercializing drugs to treat patients with serious and rare diseases. Akcea is commercializing TEGSEDI® (inotersen) and advancing a mature pipeline of novel drugs, including WAYLIVRA® (volanesorsen), AKCEA-APO(a)-LRx, AKCEA-ANGPTL3-LRx, AKCEA-APOCIII-LRx, and AKCEA-TTR-LRx, with the potential to treat multiple diseases. All six drugs were discovered by and co-developed with Ionis, a leader in antisense therapeutics, and are based on Ionis’ proprietary antisense technology. TEGSEDI is approved in the U.S., E.U. and Canada. WAYLIVRA is approved in the E.U. and is currently in Phase 3 clinical development for the treatment of people with familial partial lipodystrophy, or FPL. Akcea is building the infrastructure to commercialize its drugs globally. Akcea is a global company headquartered in Boston, Massachusetts. Additional information about Akcea is available at www.akceatx.com and you can follow us on twitter at @akceatx.

FORWARD-LOOKING STATEMENT

This press release includes forward-looking statements regarding the business of Akcea Therapeutics, Inc. and the therapeutic and commercial potential of TEGSEDI® (inotersen), WAYLIVRA® (volanesorsen) and other products in development. Any statement describing Akcea’s goals, expectations, financial or other projections, intentions or beliefs is a forward-looking statement and should be considered an at-risk statement. Such statements are subject to certain risks and uncertainties, particularly those inherent in the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics, and in the endeavor of building a business around such drugs. Akcea’s forward-looking statements also involve assumptions that, if they never materialize or prove correct, could cause its results to differ materially from those expressed or implied by such forward-looking statements. Although Akcea’s forward-looking statements reflect the good faith judgment of its management, these statements are based only on facts and factors currently known by Akcea. As a result, you are cautioned not to rely on these forward-looking statements. These and other risks concerning Akcea’s programs are described in additional detail in Akcea’s annual report on Form 10-K, and its most recent quarterly report on Form 10-Q, which are on file with the SEC. Copies of these and other documents are available from the Company.


In this press release, unless the context requires otherwise, “Ionis”, “Akcea,” “Company,” “Companies,” “we,” “our,” and “us” refers to Ionis Pharmaceuticals and/or Akcea Therapeutics.

Ionis Pharmaceuticals is a trademark of Ionis Pharmaceuticals, Inc. Akcea Therapeutic® TEGSEDI® and WAYLIVRA® are trademarks of Akcea Therapeutics, Inc.


AKCEA THERAPEUTICS INC.

SELECTED FINANCIAL INFORMATION

Condensed Consolidated Statements of Operations

(In Thousands, Except Share and Per Share Data)

 

     Three Months Ended     Six Months Ended  
     June 30,     June 30,  
     2019     2018     2019     2018  
     (unaudited)     (unaudited)  

Revenue:

        

Product revenue, net

   $ 9,865     $ —       $ 16,619     $ —    

Licensing revenue

     6,036       —         6,036       —    
  

 

 

   

 

 

   

 

 

   

 

 

 

Total commercial revenue

     15,901       —         22,655       —    

R&D and license revenue

     10,722       18,321       167,784       35,429  
  

 

 

   

 

 

   

 

 

   

 

 

 

Total revenue

     26,623       18,321       190,439       35,429  

Expenses:

        

Cost of sales and license

     5,783       —         8,227       —    

Research and development

     20,271       39,457       119,890       67,427  

Selling, general and administrative

     50,740       42,287       95,342       61,752  

Net loss share from commercial activities under arrangement with Ionis Pharmaceuticals, Inc.

     (11,465     —         (20,521     —    
  

 

 

   

 

 

   

 

 

   

 

 

 

Total expenses

     65,329       81,744       202,938       129,179  
  

 

 

   

 

 

   

 

 

   

 

 

 

Loss from operations

     (38,706     (63,423     (12,499     (93,750

Other income (expense):

        

Investment income

     1,571       1,546       2,795       2,414  

Other income (expense)

     (28     45       (140     (123
  

 

 

   

 

 

   

 

 

   

 

 

 

Loss before income tax expense

     (37,163     (61,832     (9,844     (91,459

Income tax expense

     (160     (214     (292     (214
  

 

 

   

 

 

   

 

 

   

 

 

 

Net loss

   $ (37,323   $ (62,046   $ (10,136   $ (91,673
  

 

 

   

 

 

   

 

 

   

 

 

 

Net loss per share of common stock owned by Ionis, basic and diluted

   $ (0.40   $ (0.72   $ (0.06   $ (1.19
  

 

 

   

 

 

   

 

 

   

 

 

 

Weighted-average shares of common stock outstanding owned by Ionis, basic and diluted

     70,221,338       60,832,494       69,406,181       53,182,685  
  

 

 

   

 

 

   

 

 

   

 

 

 

Net loss per share of common stock owned by others, basic and diluted

   $ (0.40   $ (0.85   $ (0.26   $ (1.33
  

 

 

   

 

 

   

 

 

   

 

 

 

Weighted-average shares of common stock outstanding owned by others, basic and diluted

     22,573,900       21,492,157       22,351,368       21,332,650  
  

 

 

   

 

 

   

 

 

   

 

 

 


AKCEA THERAPEUTICS INC.

Reconciliation of GAAP to Non-GAAP Basis:

Condensed Consolidated Operating Expenses, Loss from Operations, and Net Loss

(In Thousands)

 

     Three Months Ended     Six Months Ended  
     June 30,     June 30,  
     2019     2018     2019     2018  
     (unaudited)     (unaudited)  

As reported operating expenses according to GAAP

   $ 65,329     $ 81,744     $ 202,938     $ 129,179  

Excluding compensation expense related to equity awards

     14,363       12,126       32,923       18,509  
  

 

 

   

 

 

   

 

 

   

 

 

 

Non-GAAP operating expenses

   $ 50,966     $ 69,618     $ 170,015     $ 110,670  
  

 

 

   

 

 

   

 

 

   

 

 

 

As reported loss from operations according to GAAP

   $ (38,706   $ (63,423   $ (12,499   $ (93,750

Excluding compensation expense related to equity awards

     14,363       12,126       32,923       18,509  
  

 

 

   

 

 

   

 

 

   

 

 

 

Non-GAAP income (loss) from operations

   $ (24,343   $ (51,297   $ 20,424     $ (75,241
  

 

 

   

 

 

   

 

 

   

 

 

 

As reported net loss according to GAAP

   $ (37,323   $ (62,046   $ (10,136   $ (91,673

Excluding compensation expense related to equity awards

     14,363       12,126       32,923       18,509  
  

 

 

   

 

 

   

 

 

   

 

 

 

Non-GAAP net income (loss)

   $ (22,960   $ (49,920   $ 22,787     $ (73,164
  

 

 

   

 

 

   

 

 

   

 

 

 

Reconciliation of GAAP to non-GAAP Basis

As illustrated in the Selected Financial Information in this press release, non-GAAP operating expenses, non-GAAP income (loss) from operations, and non-GAAP net income (loss) were adjusted from GAAP to exclude compensation expense related to equity awards, which are non-cash expenses. Akcea has regularly reported non-GAAP measures for operating results as non-GAAP results. These measures are provided as supplementary information and are not a substitute for financial measures calculated in accordance with GAAP. Akcea reports these non-GAAP results to better enable financial statement users to assess and compare its historical performance and project its future operating results and cash flows. Further, the presentation of Akcea’s non-GAAP results is consistent with how Akcea’s management internally evaluates the performance of its operations.


AKCEA THERAPEUTICS INC.

Condensed Consolidated Balance Sheets

(In Thousands)

 

     June 30,      December 31,  
     2019      2018  
     (unaudited)  

Assets:

     

Cash and cash equivalents

   $ 150,234      $ 86,454  

Short-term investments

     145,374        166,155  

Accounts receivable

     9,193        4,597  

Receivable from Ionis Pharmaceuticals, Inc.

     7,911        —    

Inventory

     8,286        85  

Other current assets

     6,713        9,944  

Property, plant and equipment, net

     5,443        5,696  

Operating lease right-of-use assets

     11,534        —    

Intangible assets, net

     86,006        88,914  

Deposits and other assets

     3,426        3,416  
  

 

 

    

 

 

 

Total assets

   $ 434,120      $ 365,261  
  

 

 

    

 

 

 

Liabilities and stockholders’ equity:

     

Accounts payable

   $ 7,936      $ 12,068  

Payable to Ionis Pharmaceuticals, Inc.

     —          18,901  

Accrued compensation

     7,521        8,583  

Accrued liabilities

     17,569        14,787  

Current portion of deferred revenue

     15,830        25,354  

Other current liabilities

     1,713        968  

Long-term portion of lease liabilities

     14,909        4,442  

Long-term portion of deferred revenue

     —          3,434  

Stockholders’ equity

     368,642        276,724  
  

 

 

    

 

 

 

Total liabilities and stockholders’ equity

   $ 434,120      $ 365,261  
  

 

 

    

 

 

 

Media and Investor Contact:

Kathleen Gallagher

Vice President of Corporate Communications and Investor Relations

617.207.8509

kgallagher@akceatx.com

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