Document



 

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 3, 2016

PDL BioPharma, Inc.

(Exact name of Company as specified in its charter)

000-19756
(Commission File Number)


Delaware
 
94-3023969
(State or Other Jurisdiction of Incorporation)
 
(I.R.S. Employer Identification No.)


932 Southwood Boulevard
Incline Village, Nevada 89451
(Address of principal executive offices, with zip code)

(775) 832-8500
(Company’s telephone number, including area code)



Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the Company 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))
 








Item 2.02 Results of Operations and Financial Condition.
 
On November 3, 2016, PDL BioPharma, Inc. (the Company) issued a press release announcing its financial results for the third quarter ended September 30, 2016. A copy of this earnings release is furnished hereto as Exhibit 99.1. The Company will host an earnings call and webcast on November 3, 2016, during which the Company will discuss its financial results for the third quarter ended September 30, 2016.

Item 7.01 Regulation FD Disclosure.
 
Presentation Materials
 
On November 3, 2016, the Company posted to its website a set of presentation materials that it will use during its earnings call and webcast to assist participants with understanding the Company’s financial results for the quarter ended September 30, 2016. A copy of this presentation is attached hereto as Exhibit 99.2.
 
Information Sheet
 
On November 3, 2016, the Company distributed to analysts covering the Company’s securities a summary of certain information regarding the Company’s net income, dividends, recent transactions and licensed product development and sales (the Information Sheet) to assist those analysts in valuing the Company’s securities. The Information Sheet and its associated tables are attached hereto as Exhibit 99.3.
 
Limitation of Incorporation by Reference
 
In accordance with General Instruction B.2. of Form 8-K, the information in this report, including the exhibits, is furnished pursuant to Items 2.02 and 7.01 and shall not be deemed to be “filed” for the purpose of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section and shall not be deemed to be incorporated by reference into any filing of the Company under the Securities Act of 1933, as amended or the Exchange Act.
 
Cautionary Statements
 
This filing and its exhibits include “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we can give no assurance that such expectations will prove to be correct. Important factors that could impair the Company’s royalty assets or business are disclosed in the “Risk Factors” contained in the Company’s Annual Report on Form 10-K, filed with the Securities and Exchange Commission on February 23, 2016, as updated by subsequent periodic filings. All forward-looking statements are expressly qualified in their entirety by such factors. We do not undertake any duty to update any forward-looking statement except as required by law.

Item 9.01 Financial Statements and Exhibits.
The following exhibits are furnished with this report:
Exhibit No.
 
Description
99.1
 
Press Release
99.2
 
Presentation
99.3
 
Information Sheet






SIGNATURES

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

PDL BIOPHARMA, INC.
(Company)
 
 
 
By:
 
/s/ Peter S. Garcia
 
 
Peter S. Garcia
 
 
Vice President and Chief Financial Officer
 
 



Dated: November 3, 2016






Exhibit Index
Exhibit No.
 
Description
99.1
 
Press Release
99.2
 
Presentation
99.3
 
Information Sheet



Exhibit


Exhibit 99.1
https://cdn.kscope.io/96baeb6e7727866271d3655bdbc937bb-pdllogo2016a06.jpg
Contacts:
 
 
Peter Garcia
 
Jennifer Williams
PDL BioPharma, Inc.
 
Cook Williams Communications, Inc.
775-832-8500
 
360-668-3701
Peter.Garcia@pdl.com
 
jennifer@cwcomm.org

PDL BioPharma Announces Third Quarter 2016 Financial Results


INCLINE VILLAGE, NV, November 3, 2016 – PDL BioPharma, Inc. (PDL or the Company) (NASDAQ: PDLI) today reported financial results for the third quarter ended September 30, 2016 including:
Total revenues of $53.6 million and $177.8 million for the three and nine months ended September 30, 2016, respectively.
GAAP diluted EPS of $0.08 and $0.45 for the three and nine months ended September 30, 2016, respectively.
GAAP net income attributable to PDL's shareholders of $13.9 million and $73.9 million for the three and nine months ended September 30, 2016, respectively.
Non-GAAP net income of $18.9 million and $118.2 million for the three and nine months ended September 30, 2016, respectively.

The largest component of the difference in non-GAAP net income compared to GAAP net income is the exclusion of (i) the mark-to-market reduction in fair value of our investments in royalty rights and (ii) the amortization of intangible assets. A full reconciliation of all components of the GAAP to non-GAAP quarterly financial results can be found in Table 4 at the end of this release.

Revenue Highlights

Total revenues of $53.6 million for the three months ended September 30, 2016 included:
Royalties from PDL's licensees to the Queen et al. patents of $15.0 million, which consisted of royalties earned on sales of Tysabri® under a license agreement;
Net royalty payments from acquired royalty rights and a change in fair value of the royalty rights assets of $16.1 million, which consisted of the change in estimated fair value of our royalty right assets, primarily related to the Depomed, Inc., University of Michigan and AcelRx Pharmaceuticals, Inc. royalty rights acquisitions;
Interest revenue from notes receivable financings to late-stage healthcare companies of $8.6 million; and
Product revenues from sales of Tekturna® and Tekturna HCT® in the United States and Rasilez® and Rasilez HCT® in the rest of the world of $14.1 million.
Total revenues decreased by 57 percent for the three months ended September 30, 2016, when compared to the same period in 2015.
The decrease in royalties from PDL's licensees to the Queen et al. patents is due to the expiration of the patent license agreement with Genentech, Inc. PDL continues to receive royalties on sales of Tysabri. The duration of this royalty payment is based on the sales of product manufactured prior to patent expiry, the amount of which is uncertain.
The increase in royalty rights - change in fair value was driven by the $9.6 million increase in the fair value of the Depomed royalty rights assets primarily due to a $5.0 million milestone payment based on FDA





approval of Invokamet® XR, a Type 2 diabetes drug in our Depomed portfolio, an adjustment to the timing of its estimated cashflows and a reduction in discount rate.
PDL received $15.3 million in net cash royalty and milestone payments from its royalty rights in the third quarter of 2016, compared to $6.9 million for the same period of 2015.
The decrease in interest revenues was primarily due to ceasing to recognize interest from Direct Flow Medical, Inc. notes receivable.
Product revenues were derived from sales of Tekturna and Tekturna HCT in the United States and Rasilez and Rasilez HCT in the rest of the world (collectively, the Noden Products). Pursuant to the purchase agreement, when Noden Pharma DAC (Noden) acquired the exclusive worldwide rights to manufacture, market, and sell the Noden Products from Novartis. Novartis continued distributing the Noden Products during the third quarter of 2016 and transferred profits with Noden on a net basis (i.e. net of cost of manufacturing and a fee to Novartis). Noden is commercializing the products in the U.S. as of the fourth quarter of 2016.
Total revenues decreased by 57 percent for the nine months ended September 30, 2016, when compared to the same period in 2015.
The decrease in royalties from PDL's licensees to the Queen et al. patents is due to the expiration of the patent license agreement with Genentech, Inc.
The decrease in royalty rights - change in fair value was driven by the $19.2 million decrease in the fair value of the Depomed royalty rights asset, and a $3.4 million decrease in the fair value of the University of Michigan royalty right asset.
PDL received $47.2 million in net cash royalty payments and milestone payments from its acquired royalty rights in the nine months ended September 30, 2016, compared to $9.0 million for the same period of 2015.
Product revenues and interest revenue variances were the same as the three months ended September 30, 2016.

Operating Expense Highlights

Operating expenses were $21.0 million for the three months ended September 30, 2016, compared to $8.5 million for the same period of 2015. The increase in operating expenses for the three months ended September 30, 2016, as compared to the same period in 2015, was primarily a result of the product sales segment acquisition, contributing an additional $6.0 million of acquisition intangible amortization, $2.1 million in a change in fair value in acquisition-related contingent consideration, $1.9 million in research and development costs for the completion of a pediatric trial for the acquired branded prescription medicines Tekturna by Noden and acquisition related costs of $0.5 million. General and administrative expenses increased by $1.9 million, of which $1.1 million relates to an increased headcount and expenses due to the Noden related product acquisitions and $0.3 million relates to additional stock-based compensation expenses and an increase in legal services mostly related to ongoing legal proceedings.
Operating expenses were $40.7 million for the nine months ended September 30, 2016, compared to $23.5 million for the same period of 2015. The increase in operating expenses for the nine months ended September 30, 2016, as compared to the same period in 2015, was the result of the expenses related to the acquisition of the Noden Products.

Other Financial Highlights

PDL had cash, cash equivalents, and investments of $114.6 million at September 30, 2016, compared to $220.4 million at December 31, 2015.
The decrease was primarily attributable to the acquisition of a business, net of cash of $109.9 million, the purchase of a certificate of deposit for $75.0 million, the purchase of additional royalty rights for $59.5 million, repayment of the March 2015 Term Loan for $25.0 million, payment of dividends of $16.4 million, an additional note receivable purchase of $8.0 million, the purchase of short-term investments of $8.0 million, and the payment of debt issuance costs of $0.3 million, partially offset by the repayment of a note receivable balance of $54.7 million, proceeds from royalty right payments of $47.2 million, proceeds from the sale of available-for-sale securities of $1.7 million, cash received from a noncontrolling investor of $0.3 million and cash generated by operating activities of $86.1 million.
Net cash provided by operating activities in the nine months ended September 30, 2016 was $86.1 million, compared with $231.4 million in the same period in 2015.






Conference Call and Webcast Details

PDL will hold a conference call to discuss financial results at 4:30 p.m. Eastern Time today, November 3, 2016.
 
To access the live conference call via phone, please dial (800) 668-4132 from the United States and Canada or (224) 357-2196 internationally. The conference ID is 6554182. Please dial in approximately 10 minutes prior to the start of the call. A telephone replay will be available beginning approximately one hour after the call through November 10, 2016, and may be accessed by dialing (855) 859-2056 from the United States and Canada or (404) 537-3406 internationally. The replay passcode is 6554182.

To access the live and subsequently archived webcast of the conference call, go to the Company’s website at http://www.pdl.com and go to “Events & Presentations.” Please connect to the website at least 15 minutes prior to the call to allow for any software download that may be necessary.
 
About PDL BioPharma, Inc.

PDL seeks to optimize its return on investments so as to provide a significant return for its shareholders by acquiring and managing a portfolio of companies, products, royalty agreements and debt facilities in the biotech, pharmaceutical and medical device industries. In late 2012, PDL began providing alternative sources of capital through royalty monetizations and debt facilities and in 2016, began making equity investments in commercial stage companies, the first being Noden Pharma DAC. PDL has committed over $1.4 billion and funded approximately $1.1 billion in these investments to date.

The Company was formerly known as Protein Design Labs, Inc. and changed its name to PDL BioPharma, Inc. in 2006. PDL was founded in 1986 and is headquartered in Incline Village, Nevada. PDL pioneered the humanization of monoclonal antibodies and, by doing so, enabled the discovery of a new generation of targeted treatments for cancer and immunologic diseases for which it has received significant royalty revenue.

PDL BioPharma and the PDL BioPharma logo are considered trademarks of PDL BioPharma, Inc.

Forward-looking Statements

This press release contains "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Each of these forward-looking statements involves risks and uncertainties. Actual results may differ materially from those, express or implied, in these forward-looking statements. Important factors that could impair the value of the Company's royalty assets, restrict or impede the ability of the Company to invest in new royalty bearing assets and limit the Company's ability to pay dividends are disclosed in the risk factors contained in the Company's Annual Report on Form 10-K, filed with the Securities and Exchange Commission on February 23, 2016, as updated by subsequent periodic filings. All forward-looking statements are expressly qualified in their entirety by such factors. We do not undertake any duty to update any forward-looking statement except as required by law.





TABLE 1
PDL BIOPHARMA, INC.
CONDENSED CONSOLIDATED STATEMENTS OF INCOME DATA
(Unaudited)
(In thousands, except per share amounts)

 
 
Three Months Ended
 
Nine Months Ended
 
 
September 30,
 
September 30,
 
 
2016
 
2015
 
2016
 
2015
Revenues
 
 
 
 
 
 
 
 
Royalties from Queen et al. patents
 
$
14,958

 
$
119,222

 
$
150,645

 
$
363,916

Royalty rights - change in fair value
 
16,085

 
(4,280
)
 
(11,872
)
 
19,298

Interest revenue
 
8,594

 
9,096

 
24,901

 
28,596

Product revenue, net
 
14,128

 

 
14,128

 

License and other
 
(127
)
 
580

 
7

 
580

Total revenues
 
53,638

 
124,618

 
177,809

 
412,390

 
 
 
 
 
 
 
 
 
Operating Expenses
 
 
 
 
 
 
 
 
Amortization of intangible assets
 
6,014

 

 
6,014

 

General and administrative expenses
 
10,396

 
8,450

 
27,193

 
23,545

Sales and marketing
 
11

 

 
11

 

Research and development
 
1,933

 

 
1,933

 

Change in fair value of anniversary payment and contingent consideration
 
2,083

 

 
2,083

 

Acquisition-related costs
 
546

 

 
3,505

 

Total operating expenses
 
20,983

 
8,450

 
40,739

 
23,545

Operating income
 
32,655

 
116,168

 
137,070

 
388,845

 
 
 
 
 
 
 
 
 
Non-operating expense, net
 
 
 
 
 
 
 
 
Interest and other income, net
 
162

 
87

 
404

 
294

Interest expense
 
(4,513
)
 
(5,901
)
 
(13,524
)
 
(21,710
)
Total non-operating expense, net
 
(4,351
)
 
(5,814
)
 
(13,120
)
 
(21,416
)
 
 
 
 
 
 
 
 
 
Income before income taxes
 
28,304

 
110,354

 
123,950

 
367,429

Income tax expense
 
14,400

 
40,895

 
50,011

 
135,208

Net income
 
13,904

 
69,459

 
73,939

 
232,221

Net loss attributable to noncontrolling interests
 
3

 

 
3

 

Net income attributable to PDL's shareholders
 
$
13,907

 
$
69,459

 
$
73,942

 
$
232,221

 
 
 
 
 
 
 
 
 
Net income per share
 
 
 
 
 
 
 
 
Basic
 
$
0.08

 
$
0.42

 
$
0.45

 
$
1.42

Diluted
 
$
0.08

 
$
0.42

 
$
0.45

 
$
1.42

 
 
 
 
 
 
 
 
 
Shares used to compute income per basic share
 
163,856

 
163,560

 
163,771

 
163,314

Shares used to compute income per diluted share
 
164,285

 
163,742

 
164,075

 
163,899

 
 
 
 
 
 
 
 
 
Cash dividends declared per common share
 
$

 
$

 
$
0.10

 
$
0.60








TABLE 2
PDL BIOPHARMA, INC.
CONDENSED CONSOLIDATED BALANCE SHEET DATA
(Unaudited)
(In thousands)

 
 
September 30,
 
December 31,
 
 
2016
 
2015
Cash, cash equivalents and investments
 
$
114,575

 
$
220,352

Total notes receivable
 
$
320,997

 
$
364,905

Total royalty rights - at fair value
 
$
399,592

 
$
399,204

Total assets
 
$
1,216,066

 
$
1,012,205

Total term loan payable
 
$

 
$
24,966

Total convertible notes payable
 
$
234,895

 
$
228,862

Total stockholders' equity
 
$
753,856

 
$
695,952






TABLE 3
PDL BIOPHARMA, INC.
CONDENSED CONSOLIDATED STATEMENT OF CASH FLOW DATA
(Unaudited)
(In thousands)

 
 
Nine Months Ended
 
 
September 30,
 
 
2016
 
2015
Net income
 
$
73,939

 
$
232,221

Adjustments to reconcile net income to net cash provided by operating activities
 
22,682

 
386

Changes in assets and liabilities
 
(10,556
)
 
(1,221
)
Net cash provided by operating activities
 
$
86,065

 
$
231,386








TABLE 4
PDL BIOPHARMA, INC.
GAAP to NON-GAAP RECONCILIATION:
NET INCOME AND DILUTED EARNINGS PER SHARE
(Unaudited)
(In thousands, except per share amount)

A reconciliation between net income on a GAAP basis and on a non-GAAP basis is as follows:
 
 
 
 
 
 
 
 
 
 
 
Three Months Ended
 
Nine Months Ended
 
 
September 30,
 
September 30,
 
 
2016
 
2015
 
2016
 
2015
GAAP net income attributed to PDL's shareholders as reported
 
$
13,907

 
$
69,459

 
$
73,942

 
$
232,221

Adjustments to Non-GAAP net income (as detailed below)
 
4,960

 
10,122

 
44,211

 
(2,535
)
Non-GAAP net income attributed to PDL's shareholders
 
$
18,867

 
$
79,581

 
$
118,153

 
$
229,686

 
 
 
 
 
 
 
 
 
An itemized reconciliation between net income on a GAAP basis and on a non-GAAP basis is as follows:
 
 
 
 
 
 
 
 
 
 
 
Three Months Ended
 
Nine Months Ended
 
 
September 30,
 
September 30,
 
 
2016
 
2015
 
2016
 
2015
GAAP net income attributed to PDL's shareholders as reported
 
$
13,907

 
$
69,459

 
$
73,942

 
$
232,221

Adjustments:
 
 
 
 
 
 
 
 
Mark-to-market adjustment to fair value assets
 
(754
)
 
11,159

 
59,112

 
(10,328
)
Non-cash interest revenues
 
(468
)
 
(1,366
)
 
(2,744
)
 
(4,775
)
Non-cash stock-based compensation expense
 
1,050

 
621

 
2,649

 
1,348

Non-cash debt offering costs
 
2,048

 
5,678

 
6,067

 
9,744

Mark-to-market adjustment on warrants held
 
128

 

 
875

 

Amortization of the intangible assets
 
6,014

 

 
6,014

 

Mark-to-market adjustment of anniversary payment and contingent consideration
 
2,083

 

 
2,083

 

Income tax effect related to above items
 
(5,141
)
 
(5,970
)
 
(29,845
)
 
1,476

Total adjustments
 
4,960

 
10,122

 
44,211

 
(2,535
)
Non-GAAP net income
 
$
18,867

 
$
79,581

 
$
118,153

 
$
229,686


Use of Non-GAAP Financial Measures

We supplement our consolidated financial statements presented on a GAAP basis by providing additional measures which may be considered “non-GAAP” financial measures under applicable SEC rules. We believe that the disclosure of these non-GAAP financial measures provides our investors with additional information that reflects the amounts and financial basis upon which our management assesses and operates our business. These non-GAAP financial measures are not in accordance with generally accepted accounting principles and should not be viewed in isolation or as a substitute for reported, or GAAP, net income, and diluted earnings per share, and are not a substitute for, or superior to, measures of financial performance performed in conformity with GAAP.

“Non-GAAP net income“ is not based on any standardized methodology prescribed by GAAP and represent GAAP net income adjusted to exclude (1) mark-to market adjustments related to the fair value election for our investments in royalty rights presented in our earnings, which include the fair value re-measurement of future discounted cash flows for each of the royalty rights assets we have acquired, (2) non-cash interest revenue from notes receivable (3) stock-based compensation expense, (4) non-cash interest expense related to PDL debt offering costs, (5) mark-to market adjustments related to warrants held, (6) mark-to-market adjustment related to acquisition-related contingent considerations, (7) amortization of intangible assets, and to





adjust (7) the related tax effect of all reconciling items within our reconciliation of our GAAP to Non-GAAP net income. Non-GAAP financial measures used by PDL may be calculated differently from, and therefore may not be comparable to, non-GAAP measures used by other companies.



Exhibit


Exhibit 99.2

https://cdn.kscope.io/96baeb6e7727866271d3655bdbc937bb-slide1a25.jpg





https://cdn.kscope.io/96baeb6e7727866271d3655bdbc937bb-slide2a25.jpg





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https://cdn.kscope.io/96baeb6e7727866271d3655bdbc937bb-slide4a25.jpg





https://cdn.kscope.io/96baeb6e7727866271d3655bdbc937bb-slide5a25.jpg





https://cdn.kscope.io/96baeb6e7727866271d3655bdbc937bb-slide6a25.jpg





https://cdn.kscope.io/96baeb6e7727866271d3655bdbc937bb-slide7a25.jpg





https://cdn.kscope.io/96baeb6e7727866271d3655bdbc937bb-slide8a23.jpg





https://cdn.kscope.io/96baeb6e7727866271d3655bdbc937bb-slide9a20.jpg





https://cdn.kscope.io/96baeb6e7727866271d3655bdbc937bb-slidg01.jpg


Exhibit

Exhibit 99.3

PDL BioPharma, Inc.
Q3 2016
November 3, 2016

Following are some of the key points regarding PDL’s third quarter 2016 financial and business results.

Highlighted Financial Results from Q3 2016
Total revenues of $53.6 million and $177.8 million for the three and nine months ended September 30, 2016, respectively.
GAAP diluted EPS of $0.08 and $0.45 for the three and nine months ended September 30, 2016, respectively.
GAAP net income attributable to PDL's shareholders of $13.9 million and $73.9 million for the three and nine months ended September 30, 2016, respectively.
Non-GAAP net income of $18.9 million and $118.2 million for the three and nine months ended September 30, 2016, respectively.

The largest component of the difference in non-GAAP net income compared to GAAP net income is the exclusion of (i) the mark-to-market reduction in fair value of our investments in royalty rights and (ii) the amortization of intangible assets. A full reconciliation of all components of the GAAP to non-GAAP quarterly financial results can be found in Table 4 at the end of our press release.
Updates on royalty-bearing products relating to Queen et al. Patents

Tysabri® (Approved royalty-bearing product relating to Queen et al. patents)
Continue to receive royalties on Tysabri from Biogen with respect to sales of the licensed product manufactured prior to patent expiry in jurisdictions providing patent protection licenses.
Q3 2016 PDL royalty revenue was $15.0 million based upon Biogen’s sales from Q2 2016.
Historical royalty and sales data is listed [in the table below.]

Solanezumab (Unapproved royalty-bearing product relating to Queen et al. patents)
Lilly reported that completed enrollment and continuing patient follow up on Phase 3 clinical trial.
Top line data from Phase 3 trial in mild Alzheimer’s disease expected in December 2016. Lilly expected to file for product approval in 1H17 if data are positive.
PDL has a 2% know-how royalty on solanezumab which runs for 12.5 years from the date of its first sale.

Noden Pharma
On July 1, 2016, Noden Pharma DAC, a newly-formed company organized under the laws of Ireland purchased from Novartis the exclusive worldwide rights to manufacture, market, and sell the branded prescription medicine product sold under the name Tekturna® and Tekturna HCT® in the United States and Rasilez® and Rasilez HCT® in the rest of the world (collectively the "Noden Products") and certain related assets and will assume certain related liabilities in exchange for the following cash commitments: $110.0 million paid on July 1, 2016, the closing date of the acquisition, $89.0 million payable on the first anniversary of the closing date and up to $95.0 million of additional cash consideration contingent on achievement of sales targets and the date of the launch of a generic drug containing the pharmaceutical ingredient aliskiren.
On July 1, 2016, PDL entered into an investment and stockholders’ agreement with Noden Pharma DAC and an affiliate and certain members of Noden’s management. PDL acquired an approximately 99% equity stake and obtained the majority voting power of Noden, for a total cash consideration of $75.0 million. It is expected that PDL’s equity ownership stake will ultimately be reduced to 88% upon the vesting of shares granted to Noden's noncontrolling interest holders.

Page 1

PDL BioPharma, Inc.
Q3 2016
November 3, 2016


In July 2016, Noden began earning profits on the sale of Tekturna, Tekturna HCT, Rasilez and Rasilez HCT. During the transitional service period, we expect to receive monthly reporting from Novartis, that is, generally after Novartis has sold the Noden Products. We recognize revenue when we can reliably estimate such amounts and collectability is reasonably assured.
Product revenues were derived from sales of the Noden Products. Pursuant to the purchase agreement, when Noden Pharma DAC (Noden) acquired the exclusive worldwide rights to manufacture, market, and sell the Noden Products from Novartis. Novartis was required to continue distributing the Noden Products during the third quarter of 2016 and transferred profits with Noden on a net basis (i.e. net of cost of manufacturing and a fee to Novartis). Noden is commercializing the products in the U.S. as of the fourth quarter of 2016.

Updates on Income Generating Assets

Royalty Rights Assets
The following table provides additional details with respect the fair value of the PDL royalty rights assets as of December 31, 2015 and with changes to September 30, 2016 as reflected in our Balance Sheet:
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Fair Value as of
 
New Royalty
 
Royalty Rights -
 
Fair Value as of
 
 
Dec. 31, 2015
 
Assets
 
Change in Fair Value
 
Sept. 30, 2016
 
Depomed
$
191,865
 
 
$
0
 
 
 
$
(57,559
)
 
 
$
134,306
 
VB
17,133
 
 
0
 
 
 
(2,328
)
 
 
14,805
 
U-M
70,186
 
 
0
 
 
 
(5,549
)
 
 
64,637
 
ARIAD
50,041
 
 
50,000
 
 
 
103
 
 
 
100,144
 
AcelRx
67,437
 
 
0
 
 
 
6,612
 
 
 
74,049
 
Avinger
2,542
 
 
0
 
 
 
(667
)
 
 
1,875
 
KYBELLA
0
 
 
9,500
 
 
 
276
 
 
 
9,776
 
 
$
399,204
 
 
$
59,500
 
 
 
$
(59,112
)
 
 
$
399,592
 

The following table provides additional details with respect PDL royalty rights - change in fair value for the nine months ended September 30, 2016 and reflected in our Income Statement:
 
 
 
 
Change in
 
Royalty Rights -
 
 
Cash Royalties
 
Fair Value
 
Change in Fair Value
Depomed
$
38,383
 
 
$
(57,559
)
 
$
(19,176
)
 
VB
 
1,142
 
 
 
(2,328
)
 
 
(1,186
)
 
U-M
 
2,199
 
 
 
(5,549
)
 
 
(3,350
)
 
ARIAD
4,575
 
 
103
 
 
 
4,678
 
 
AcelRx
3
 
 
6,612
 
 
 
6,615
 
 
Avinger
915
 
 
(667
)
 
 
248
 
 
KYBELLA
23
 
 
276
 
 
 
299
 
 
 
$
47,240

 
$
(59,112
)
 
 
$
(11,872
)
 


Page 2

PDL BioPharma, Inc.
Q3 2016
November 3, 2016


Updates on Royalty Rights Assets
Depomed, Inc.
We have reduced the fair value of the Depomed royalty rights year to date 2016 by $57.6 million, primarily due to a reduction in Glumetza royalties received and a reduction in future cash flows due to lower projected demand data, greater erosion of market share due to the launch of a generic, and higher gross-to-net adjustments for Glumetza. As you will recall, Glumetza was marketed by Salix until its acquisition by Valeant. Because we have limited information from Valeant, we employ an independent third party consulting group to assist us in our quarterly evaluation of Glumetza and the other Depomed products on which we receive or will receive royalties. In February and August 2016, generic competitors to Glumetza launched as expected. The impact of the generic on pricing and gross-to-net has been greater than typical generic models would predict.

PDL received a $6 million milestone payment for FDA approval of Jentadueto® XR in the second quarter of 2016. Jentadueto XR is the third approved product for which we will receive royalties from our Depomed royalty rights assets. We expect to begin receiving royalties on Jentadueto XR in the fourth quarter of 2016.

On September 21, 2016, the Company obtained a notification indicating that the FDA approved Invokamet XR for use in patients with Type 2 diabetes. The product approval triggered a $5.0 million approval milestone payment to the Company. Based on the FDA approval and expected product launch, the Company adjusted the timing of future cash flows and discount rate used in the discounted cash flow model at September 30, 2016.

Since PDL’s acquisition of the Depomed royalty rights in October 2013, PDL has received $185.6 million in net cash payments.

PDL and Depomed are in the process of conducting a royalty audit on Glumetza royalties owed by Valeant.

Glumetza royalty payment for October 2016 is $8 million, which will be included in PDL’s fourth quarter results. 

ARIAD Pharmaceuticals, Inc.
On July 28, 2016, PDL funded the second tranche of $50 million to ARIAD. This agreement was entered into in July 2015, in exchange for royalties on the net revenues of Iclusig. As a result of the second tranche payment, under the terms of the ARIAD Royalty Agreement, PDL’s royalty percentage increased to 5.0% of the U.S. and European net revenues of Iclusig and 5.0% of the payments ARIAD receives elsewhere in the world until December 31, 2018.  Beginning January 1, 2019 and thereafter, the royalty rate will increase to 6.5% in all jurisdictions and continue until December 31, 2033, subject to a put option of PDL upon the occurrence of specified events and a call option of ARIAD.

On October 31, 2016, Ariad reported that its application for approval for brigatinib had been accepted for filing by the FDA and was granted Priority Review. Brigatinib is a backup source of repayment to PDL in the Ariad transaction.

KYBELLA Royalty Agreement
On July 8, 2016, PDL entered into a royalty purchase agreement with an individual, whereby the Company acquired that individual's rights to receive certain royalties on sales of KYBELLA® by Allergan, in exchange for a $9.5 million cash payment and up to $1.0 million in future milestone payments based upon product sales targets. The first revenues on this transaction were recognized in Q3 2016.




Page 3

PDL BioPharma, Inc.
Q3 2016
November 3, 2016


Notes Receivable
The following tables present the carrying value and fair value of notes receivevable held by PDL:
 
 
September 30, 2016
 
December 31, 2015
 
 
 
Carrying Value
 
Fair Value
Level 2
 
Fair Value
Level 3
 
Carrying Value
 
Fair Value
Level 2
 
Fair Value
Level 3
(In thousands)
 
 
 
 
 
 
 
 
 
 
 
 
Assets:
 
 
 
 
 
 
 
 
 
 
 
 
Wellstat Diagnostics note receivable
 
$
50,191

 
 
$

 
 
$
52,688
 
 
$
50,191
 
 
$

 
 
$
55,970
 
Hyperion note receivable
1,200
 
 
 
 
 
1,200
 
 
1,200
 
 
 
 
 
1,200
 
LENSAR note receivable
43,909
 
 
 
 
 
43,909
 
 
42,271
 
 
 
 
 
42,618
 
Direct Flow Medical note receivable
60,111
 
 
 
 
 
62,484
 
 
51,852
 
 
 
 
 
51,992
 
Paradigm Spine note receivable
 
 
 
 
 
0
 
 
53,973
 
 
 
 
 
54,250
 
kaléo note receivable
146,707
 
 
 
 
 
143,884
 
 
146,778
 
 
 
 
 
146,789
 
CareView note receivable
18,879
 
 
 
 
 
20,168
 
 
18,640
 
 
 
 
 
19,495
 
Total
 
$
320,997

 
 
$

 
 
$
324,333
 
 
$
364,905
 
 
$

 
 
$
372,314
 

Updates on Notes Receivable

Wellstat Diagnostics, LLC
On July 29, 2016, the Supreme Court of New York issued its Memorandum of Decision granting the Company’s motion for summary judgment and denying the Wellstat Diagnostics Guarantors’ cross-motion for summary judgment.  The Supreme Court of New York held that the Wellstat Diagnostics Guarantors are liable for all “Obligations” owed by Wellstat Diagnostics to PDL.  It did not set a specific dollar amount due, but ordered that a judicial hearing officer or special referee be designated to determine the amount of the Obligations owing, and awarded PDL its attorneys’ fees and costs in an amount to be determined.  The Supreme Court of New York has also set a hearing on August 23, 2016 to consider the implication of the status quo ante instruction on certain actions of the Wellstat Diagnostics Guarantors and whether to issue a writ of attachment.

On September 1, 2016, the Company filed a motion for relief pursuant to New York law (i) restraining the Wellstat Diagnostics Guarantors from making any sale, assignment, transfer or interference in any of their property, or from paying over or otherwise disposing of any debt, and (ii) authorizing the Company to examine the assets of each of the Wellstat Diagnostics Guarantors.

On October 5, 2016, the Wellstat Diagnostics Guarantors filed a motion for leave of the court to assert counterclaims against the Company, and certain officers and consultants of the Company, for (i) breach of fiduciary duty, (ii) intentional interference with prospective economic advantage, (iii) breach of the duty of good faith and fair dealing, and negligent misrepresentation. A hearing has been scheduled by the court regarding such motions and counterclaims for November 14, 2016.


Page 4

PDL BioPharma, Inc.
Q3 2016
November 3, 2016


On October 24, 2016, in response to a request from the Wellstat Guarantors’ to stay the damages hearing pending resolution of the Wellstat Guarantors’ appeal of the Supreme Court’s summary judgment against them by the Appellate Division, a single justice of the Appellate Division granted a temporary stay of all proceedings before the Supreme Court until the Wellstat Guarantors’ motion to stay can be addressed by a three judge panel of the Appellate Division. The motion for a stay will be fully briefed and submitted for decision by the motions panel on November 9, 2016.

Direct Flow Medical, Inc.
On July 15, 2016, PDL and Direct Flow Medical entered into the fifth Amendment and Limited Waiver to the Credit Agreement. PDL funded an additional $1.5 million to Direct Flow Medical in the form of a note with substantially the same interest and payment terms as the existing loans and a conversion feature whereby the $1.5 million loan would convert into equity of Direct Flow Medical upon the occurrence of certain events.

On September 12, 2016, the Company and Direct Flow Medical entered into the sixth amendment and limited waiver to the credit agreement under which the Company funded an additional $1.5 million to Direct Flow Medical in the form of a note with substantially the same interest and payment terms as the existing loans. In addition, Direct Flow Medical agreed to issue to the Company a specified amount of warrants to purchase shares of convertible preferred stock at an exercise price of $0.01 per share.

On September 30, 2016, the Company and Direct Flow Medical entered into the tenth limited waiver to the credit agreement where the parties agreed, among other things, to (i) delay payment on all overdue interest payments until October 31, 2016, (ii) waive the initial principal repayment until October 31, 2016 and (iii) continue to waive the liquidity requirements until October 31, 2016. Further, Direct Flow Medical agreed to issue to the Company a specified amount of warrants to purchase shares of convertible preferred stock at an exercise price of $0.01 per share.

On October 31, 2016 the Company agreed to extend the waivers described above until November 30, 2016 and is exploring its options while Direct Flow Medical continues to seek additional financing.

Paradigm Spine Credit Agreement
On August 26, 2016, the Company received $57.5 million in connection with the prepayment of the loans under the Paradigm Spine Credit Agreement, which included a repayment of the full principal amount outstanding of $54.7 million, plus accrued interest and a prepayment fee.

kaleo, Inc.
PDL entered into a secured note purchase agreement with Accel 300, a wholly-owned subsidiary of kaléo, which as of June 30, 2016, had a principal balance of $144.8 million due to PDL. Interest payments due have been paid on time and in full through the second quarter of 2016, and kaléo has indicated that it intends to make payments due to PDL under the note agreement until Auvi-Q is returned to the market.
In October 2016, kaleo announced that Auvi-Q will be reintroduced to the market in the first half of 2017. kaleo indicated that the manufacturing problems experienced when Sanofi was making the product have been resolved by kaleo’s investment in an extensive new, automated manufacturing process that uses a production line composed entirely of robots with more than one hundred quality checks.




Page 5

PDL BioPharma, Inc.
Q3 2016
November 3, 2016


Forward-looking Statements
This document contains "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Each of these forward-looking statements involves risks and uncertainties. Actual results may differ materially from those, express or implied, in these forward-looking statements. Important factors that could impair the value of the Company's royalty assets, restrict or impede the ability of the Company to invest in new income generating assets and limit the Company's ability to pay dividends are disclosed in the risk factors contained in the Company's Annual Report on Form 10-K, as updated by subsequent quarterly reports filed with the Securities and Exchange Commission, as updated by subsequent filings. All forward-looking statements are expressly qualified in their entirety by such factors. We do not undertake any duty to update any forward looking statement except as required by law.


Page 6

PDL BioPharma, Inc.
Q3 2016
November 3, 2016


Queen et al. Royalties
Royalty Revenue by Product ($ in 000's) *
Tysabri
Q1
Q2
Q3
Q4
Total
2016
13,970

14,232

14,958


43,160

2015
14,385

13,614

13,557

14,031

55,587

2014
12,857

13,350

16,048

15,015

57,270

2013
12,965

13,616

11,622

12,100

50,304

2012
11,233

12,202

11,749

12,255

47,439

2011
9,891

10,796

11,588

11,450

43,725

2010
8,791

8,788

8,735

9,440

35,754

2009
6,656

7,050

7,642

8,564

29,912

2008
3,883

5,042

5,949

6,992

21,866

2007
839

1,611

2,084

2,836

7,370

2006



237

237

* As reported to PDL by its licensees. Totals may not sum due to rounding.



Page 7

PDL BioPharma, Inc.
Q3 2016
November 3, 2016



Queen et al. Sales Revenue
Reported Licensee Net Sales Revenue by Product ($ in 000's) *
Tysabri
Q1
Q2
Q3
Q4
Total
2016
465,647

474,379

498,618


1,438,644

2015
479,526

453,786

451,898

467,735

1,852,945

2014
428,561

442,492

534,946

500,511

1,906,510

2013
434,677

451,358

387,407

403,334

1,676,776

2012
374,430

401,743

391,623

408,711

1,576,508

2011
329,696

356,876

388,758

381,618

1,456,948

2010
293,047

287,925

293,664

316,657

1,191,292

2009
221,854

229,993

257,240

285,481

994,569

2008
129,430

163,076

200,783

233,070

726,359

2007
30,468

48,715

71,972

94,521

245,675

2006



7,890

7,890

* As reported to PDL by its licensee. Dates in above charts reflect when PDL receives
royalties on sales. Sales occurred in the quarter prior to the dates in the above charts.
Totals may not sum due to rounding.
 


Page 8