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):  November 13, 2014

 

Aastrom Biosciences, Inc.

(Exact name of registrant as specified in its charter)

 

Michigan

 

000-22025

 

94-3096597

(State or other jurisdiction

 

(Commission

 

(I.R.S. Employer

of incorporation)

 

File Number)

 

Identification No.)

 

24 Frank Lloyd Wright Drive, Lobby K
Ann Arbor, Michigan

 

48105

(Address of principal executive offices)

 

(Zip Code)

 

Registrant’s telephone number, including area code:  (734) 418-4400

 

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:

 

o  Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
o  Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
o  Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
o  Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

 

 



 

Item 2.02.  Results of Operations and Financial Condition

 

On November 13, 2014, the Registrant issued a press release, a copy of which is attached hereto as Exhibit 99.1 and is incorporated herein by reference.

 

Item 9.01.  Financial Statements and Exhibits.

 

Exhibit 99.1

Press release, dated November 13, 2014.

 

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SIGNATURE

 

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.

 

 

Date:  November 13, 2014

Aastrom Biosciences, Inc.

 

 

 

 

 

By:

/s/ Gerard Michel

 

Name:

Gerard Michel

 

Title:

Chief Financial Officer, and Vice President,

 

 

Corporate Development

 

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Exhibit 99.1

 

Aastrom Biosciences Reports Third-Quarter 2014 Financial Results

 

Conference Call Today at 8:30 a.m. Eastern Time

 

ANN ARBOR, Mich., November 13, 2014 (GLOBE NEWSWIRE) — Aastrom Biosciences, Inc. (Nasdaq: ASTM), a leading developer of patient-specific expanded cellular therapies for the treatment of severe diseases and conditions, today reported financial results for the quarter ended September 30, 2014.  The results for the three months ended September 30, 2014 incorporate the first full quarter of operating results following the May 30, 2014 acquisition of Sanofi’s cell therapy and regenerative medicine business (the acquired business).

 

Aastrom reported a net loss for the quarter ended September 30, 2014 of $6.9 million, or $0.82 per share, compared to a net loss of $2.3 million, or $1.20 per share, for the same period a year ago.  The results include a one-time $3.2 million charge to earnings in connection with a settlement agreement that eliminates all future milestone payments related to the development and commercialization of MACI™ in the United States. Excluding the $3.2 million charge, the net loss for the quarter ended September 30, 2014 was $3.8 million, or $0.52 per share.

 

The acquired business generated $1.0 million of positive contribution for the period, including $0.4 million in restructuring charges and losses from operations in Denmark, which is expected to be shut down by the end of the year.  Adjusting for those items, the acquired business contributed $1.4 million in the third quarter.

 

Net revenues for the quarter ended September 30, 2014 were $9.7 million and were comprised of approximately $7.5 million of net sales of Carticel® implants and surgical kits, approximately $1.8 million of net sales of Epicel®, $0.2 million of sales of MACI from the Denmark subsidiary, and approximately $0.2 million of revenue from commercial sales of bone marrow generated by Marrow Donation, LLC.

 

Gross profit for the quarter ended September 30, 2014 was $4.1 million.  Gross profit was reduced for this period by $0.2 million of charges included in cost of goods sold related to the restructuring of the acquired business.

 

Research and development expenses for the quarter ended September 30, 2014 were $7.8 million versus $2.6 million for the same period a year ago.  The increase in research and development expenses is due to the $3.2 million charge related to the settlement agreement that eliminates all future milestone payments related to the development and commercialization of MACI in the United States, $0.8 million of additional expenses from the newly acquired business, and a $1.3 million increase in clinical trial expenses resulting from increased enrollment in the Phase 2b ixCELL-DCM clinical trial of ixmyelocel-T for the treatment of advanced heart failure due to ischemic dilated cardiomyopathy (DCM).

 

Selling, general and administrative expenses for the quarter ended September 30, 2014 were $4.3 million compared to $1.1 million for the same period a year ago.  The increase in SG&A expenses is due to approximately $1.9 million in sales and marketing expenses from the newly acquired business, approximately $0.8 million in increased IT, legal consulting and personnel costs related to integrating

 

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and managing the acquired business in the U.S. and $0.6 million in SG&A costs related to the acquired business in Denmark, which is expected to be shut down by the end of the year.

 

Other income for the quarter ended September 30, 2014 was $1.1 million compared to $1.4 million for the same period a year ago.  The decrease in other income is due primarily to the non-cash change in the fair value of warrants as well as the impact of the exercise of warrants in the third quarter of 2014.

 

As of September 30, 2014, the company had $37.6 million in cash and cash equivalents compared to $8.1 million in cash and cash equivalents at December 31, 2013.

 

Recent Business Highlights

 

During and since the third quarter of 2014, the company:

 

·                  Achieved $1.0 million in positive contribution from the acquired business, or $1.4 million excluding Denmark operations and restructuring charges;

·                  Raised gross proceeds of $40.25 million through an underwritten public offering of common stock and the full exercise of the underwriters’ option to purchase additional shares;

·                  Achieved enrollment and treatment of more than 80% of patients in the Phase 2b ixCELL-DCM clinical trial of ixmyelocel-T for the treatment of advanced heart failure due to ischemic dilated cardiomyopathy (DCM);

·                  Announced that results from the Phase 2a clinical studies of ixmyelocel-T in DCM patients were published in the peer-reviewed journal Circulation Research, demonstrating that treatment with ixmyelocel-T reduced the incidence of major adverse cardiovascular events in patients with ischemic DCM;

·                  Announced that three-year results from the SUMMIT extension study on the clinical efficacy and safety of MACI for treating cartilage defects will be presented at the American Academy of Orthopedic Surgeons (AAOS) 2015Annual Meeting;

·                  Ceased manufacturing of MACI in Denmark, consolidated manufacturing of commercial products in Cambridge, and gained EMA approval to suspend the MACI license in Europe for up to three years;

·                  Eliminated up to $15.8 million in future milestone payments relating to the development and commercialization of MACI in the United States for a one-time payment of approximately $3.2 million;

·                  Announced plans to change its corporate name to Vericel Corporation and move its corporate headquarters to Cambridge, Massachusetts.

 

“I’m very encouraged by the performance of our commercial business for the third quarter, which reflects the positive changes that we are making with our business during this transition period,” said Nick Colangelo, president and chief executive officer of Aastrom. “In addition, our recent stock offering has put us in a stronger financial position to execute our clinical and commercial programs and enables new opportunities for product development and growth.”

 

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Conference Call Information

 

Aastrom’s management will host a conference call to discuss these results today at 8:30 a.m. Eastern time.  Interested parties should call toll-free (877) 312-5881, or from outside the U.S. (253) 237-1173 and use conference ID 29268567.  The call will be available live in the Investors section of Aastrom’s website at http://investors.aastrom.com/investors.cfm.  A replay of the call will be available until November 17, 2014 by calling (855) 859-2056, or from outside the U.S. at (404) 537-3406 and using conference ID 29268567.

 

About Aastrom Biosciences

 

Aastrom Biosciences is a leader in developing patient-specific expanded cellular therapies for use in the treatment of patients with severe diseases and conditions. Aastrom markets two autologous cell therapy products in the United States for the treatment of cartilage repair and skin replacement. Aastrom is also developing MACI™, a third-generation autologous chondrocyte implant for the treatment of cartilage defects in the knee, and ixmyelocel-T, a patient-specific multicellular therapy for the treatment of advanced heart failure due to ischemic dilated cardiomyopathy.  For more information, please visit Aastrom’s website at www.aastrom.com.

 

The Aastrom Biosciences, Inc. logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=3663

 

This document contains forward-looking statements, including, without limitation, statements concerning anticipated progress, objectives and expectations regarding the commercial potential of our products and growth in revenues, intended product development, clinical activity timing, integration of the acquired business, and objectives and expectations regarding our company described herein, all of which involve certain risks and uncertainties. These statements are often, but are not always, made through the use of words or phrases such as “anticipates,” “intends,” “estimates,” “plans,” “expects,” “we believe,” “we intend,” and similar words or phrases, or future or conditional verbs such as “will,” “would,” “should,” “potential,” “could,” “may,” or similar expressions. Actual results may differ significantly from the expectations contained in the forward-looking statements. Among the factors that may result in differences are the inherent uncertainties associated with competitive developments, integration of the acquired business, clinical trial and product development activities, regulatory approval requirements, the availability and allocation of resources among different potential uses, estimating the commercial potential of our products and product candidates and growth in revenues, market demand for our products, and our ability to supply or meet customer demand for our products.  These and other significant factors are discussed in greater detail in Aastrom’s Annual Report on Form 10-K for the year ended December 31, 2013, filed with the Securities and Exchange Commission (“SEC”) on March 13, 2014, Quarterly Reports on Form 10-Q and other filings with the SEC. These forward-looking statements reflect management’s current views and Aastrom does not undertake to update any of these forward-looking statements to reflect a change in its views or events or circumstances that occur after the date of this release except as required by law.

 

3



 

AASTROM BIOSCIENCES, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(Unaudited, amounts in thousands)

 

 

 

September 30,

 

December 31,

 

 

 

2014

 

2013

 

ASSETS

 

 

 

 

 

 

 

 

 

 

 

Current assets:

 

 

 

 

 

Cash

 

$

37,578

 

$

8,059

 

Accounts receivable

 

3,959

 

8

 

Inventory

 

1,711

 

 

Other current assets

 

1,468

 

409

 

Total current assets

 

44,716

 

8,476

 

Property and equipment, net

 

2,398

 

739

 

Intangible assets

 

3,267

 

 

Total assets

 

$

50,381

 

$

9,215

 

 

 

 

 

 

 

LIABILITIES AND SHAREHOLDERS’ EQUITY

 

 

 

 

 

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

Accounts payable and accrued expenses

 

$

3,390

 

$

2,676

 

Accrued employee benefits

 

2,176

 

620

 

Verigen payment liability

 

3,158

 

 

Restructuring reserve and asset retirement obligation

 

2,511

 

 

Current portion of long-term debt

 

38

 

6

 

Warrant liabilities

 

1,209

 

2,019

 

Total current liabilities

 

12,482

 

5,321

 

Long term debt:

 

115

 

 

Total liabilities

 

12,597

 

5,321

 

COMMITMENTS AND CONTINGENCIES

 

 

 

 

 

Shareholders’ equity:

 

 

 

 

 

Series B-2 voting convertible preferred stock, no par value: shares authorized and reserved — 39, shares issued and outstanding — 12

 

38,389

 

38,389

 

Common stock, no par value; shares authorized — 75,000 and 15,000; shares issued and outstanding — 23,786 and 4,723, respectively

 

304,780

 

253,270

 

Other comprehensive income

 

(70

)

 

Accumulated deficit

 

(305,315

)

(287,765

)

Total shareholders’ equity

 

37,784

 

3,894

 

Total liabilities and shareholders’ equity

 

$

50,381

 

$

9,215

 

 

4



 

AASTROM BIOSCIENCES, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(Unaudited, amounts in thousands except per share amounts)

 

 

 

Three Months Ended
September 30,

 

Nine Months Ended
September 30,

 

 

 

2014

 

2013

 

2014

 

2013

 

Revenues:

 

 

 

 

 

 

 

 

 

Product sales

 

$

9,658

 

$

0

 

$

14,090

 

$

11

 

Total revenues

 

9,658

 

0

 

14,090

 

11

 

Costs and expenses:

 

 

 

 

 

 

 

 

 

Cost of product sales

 

5,532

 

0

 

10,541

 

3

 

Gross profit

 

4,126

 

0

 

3,549

 

8

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

7,835

 

2,575

 

15,470

 

11,789

 

Selling, general and administrative

 

4,313

 

1,066

 

9,267

 

4,259

 

Total operating expenses

 

12,148

 

3,641

 

24,737

 

16,048

 

Loss from operations

 

(8,022

)

(3,641

)

(21,188

)

(16,040

)

Other income (expense):

 

 

 

 

 

 

 

 

 

(Increase) decrease in fair value of warrants

 

949

 

1,367

 

(155

)

3,331

 

Bargain purchase gain

 

 

 

3,634

 

 

Foreign currency translation gain

 

154

 

 

154

 

 

Interest income

 

3

 

4

 

9

 

12

 

Interest expense

 

(1

)

(3

)

(4

)

(9

)

Total other income (expense)

 

1,105

 

1,368

 

3,638

 

3,334

 

Net loss

 

$

(6,917

)

$

(2,273

)

$

(17,550

)

$

(12,706

)

Net loss per share attributable to common shareholders (Basic and Diluted)

 

$

(0.82

)

$

(1.20

)

$

(2.90

)

$

(6.60

)

Weighted average number of common shares outstanding (Basic and Diluted)

 

10,273

 

3,042

 

7,569

 

2,526

 

 

5



 

AASTROM BIOSCIENCES, INC.

CONDENSED STATEMENT OF OPERATIONS — LEGACY AND ACQUIRED BUSINESS

(Unaudited, amounts in thousands except per share amounts)

 

 

 

For the Three and Nine months ended September 30, 2014

 

 

 

For the Three Months Ended September 30, 2014

 

For the Nine Months Ended September 30, 2014

 

 

 

Legacy
Business

 

Acquired
Business

 

Consolidated

 

Legacy
Business

 

Acquired
Business

 

Consolidated

 

Total revenues

 

$

244

 

$

9,414

 

$

9,658

 

$

303

 

$

13,787

 

$

14,090

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Cost of product sales

 

222

 

5,310

 

5,532

 

309

 

10,232

 

10,541

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Gross profit (loss)

 

22

 

4,104

 

4,126

 

(6

)

3,555

 

3,549

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Total operating expenses

 

9,028

 

3,120

 

12,148

 

19,525

 

5,212

 

24,737

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Income (loss) from Operations

 

(9,006

)

984

 

(8,022

)

(19,531

)

(1,657

)

(21,188

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Other income (expense)

 

1,105

 

 

1,105

 

4

 

 

4

 

Bargain purchase gain

 

 

 

 

3,634

 

 

3,634

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Total other income

 

1,105

 

 

1,105

 

3,638

 

 

3,638

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net Income (loss)

 

$

(7,901

)

$

984

 

$

(6,917

)

$

(15,893

)

$

(1,657

)

$

(17,550

)

 

6



 

NON-GAAP FINANCIAL MEASURES

 

In addition to the results reported in accordance with generally accepted accounting principles in the United States (GAAP), management is providing information regarding three non-GAAP financial measures.

 

Contribution from the acquired business:

 

The results for the three months ended September 30, 2014 incorporate the first full quarter of operating results following the May 30, 2014 acquisition of Sanofi’s cell therapy and regenerative medicine business.  The Company is providing this non-GAAP financial measure to help investors better understand the future impact of the acquired business on Aastrom’s financial performance after certain costs, severance payments and other costs associated with the restructure activities.  During the quarter ended September 30, 2014, management used this non-GAAP financial measure in making decisions related to the operations of the acquired business because, in addition to meaningful supplemental information regarding the future operating performance of the acquired business, the measure gives us a better understanding of the acquired business and the resources we should devote to successfully integrating the acquired business and ultimately achieve profitability.

 

Adjusted net loss:

 

During the quarter, the Company recorded a charge to earnings in connection with a settlement agreement that eliminates all future milestones related to the development and commercialization of MACI™ in the United States. The amount significantly increased research and development costs, and the quarter’s net loss.  During the quarter, management evaluated the operations excluding this amount, and believes this non-GAAP financial measure is important to understand the results of the business.

 

Adjusted Earnings Per Share (EPS):

 

The adjusted EPS is similar to Adjusted net loss as it incorporates the EPS impacts of the settlement agreement that eliminates all future milestones related to the development and commercialization of MACI™ in the United States. The amount significantly impacted EPS and management believes this non-GAAP financial measure is meaningful information.

 

The non-GAAP measures are intended only as a supplement to the comparable GAAP measurements and the Company compensated for the limitations inherent in the use of these non-GAAP measures by using GAAP measures in conjunction with the non-GAAP measures. As a result, investors should consider these non-GAAP measures in addition to, and not in substitution for or as superior to, the comparable measurement of financial performance prepared in accordance with GAAP.

 

7



 

Non-GAAP Financial Measures:

(in thousands of dollars):

 

Contribution from acquired business — Non-GAAP

 

2014

 

Net loss — GAAP - for the three months ended September 30, 2014

 

$

(6,917

)

Legacy business loss

 

7,901

 

Subtotal — Acquired business results

 

984

 

Restructure costs

 

77

 

Denmark business results

 

381

 

Contribution from acquired business — for the three months ended September 30, 2014 - Non-GAAP

 

$

1,442

 

 

Adjusted net loss — Non-GAAP

 

2014

 

Net loss - GAAP — for the three months ended September 30, 2014

 

$

(6,917

)

Impact of accrued expense for the Verigen agreement

 

3,158

 

Adjusted Net loss — for the three months ended September 30, 2014 - Non-GAAP

 

$

(3,759

)

 

Adjusted earnings per share (EPS) — Non-GAAP

 

2014

 

EPS - for the three months ended September 30, 2014 — GAAP

 

$

(0.82

)

Impact of accrued expense for the Verigen agreement

 

0.30

 

Adjusted Net loss — for the three months ended September 30, 2014 - Non-GAAP

 

$

(0.52

)

 

CONTACT:          Media contact:

David Salisbury

Berry & Company

dsalisbury@berrypr.com

(212) 253-8881

 

Investor contact:

Chad Rubin

The Trout Group

crubin@troutgroup.com

(646) 378-2947

 

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