Delaware | 94-3023969 | |
(State or Other Jurisdiction of Incorporation) | (I.R.S. Employer Identification No.) |
Exhibit No. | Description | |
99.1 | ||
99.2 | ||
99.3 |
PDL BIOPHARMA, INC. | ||
(Company) | ||
By: | /s/ Peter S. Garcia | |
Peter S. Garcia | ||
Vice President and Chief Financial Officer | ||
Exhibit No. | Description | |
99.1 | ||
99.2 | ||
99.3 |
Contacts: | ||
Peter Garcia | Jody Cain | |
PDL BioPharma, Inc. | LHA Investor Relations | |
775-832-8500 | 310-691-7100 | |
Peter.Garcia@pdl.com | jcain@lhai.com |
• | Total revenues of $67.9 million. |
• | GAAP net income attributable to PDL’s shareholders of $25.6 million or $0.18 per share. |
• | Non-GAAP net income attributable to PDL’s shareholders of $12.3 million. A reconciliation of GAAP to non-GAAP financial results can be found in Table 3 at the end of this news release. |
• | Cash and cash equivalents of $401.0 million as of September 30, 2018. |
• | Completed a $25.0 million share repurchase program authorized in September 2017 by repurchasing 0.6 million shares of common stock in the open market during the quarter for $1.4 million. |
• | Announced new share repurchase program of up to $100.0 million. |
• | Total revenues of $67.9 million for the three months ended September 30, 2018 included: |
◦ | Product revenues of $24.4 million, which consisted of $17.8 million from sales of Tekturna® and Tekturna HCT® in the U.S. and Rasilez® and Rasilez HCT® in the rest of the world (collectively, the Noden Products), and $6.6 million for product revenue from the LENSAR® Laser System; |
◦ | Net royalty payments from acquired royalty rights and a change in fair value of the royalty rights assets of $42.2 million, primarily related to the Assertio royalty asset; |
◦ | Royalties from PDL’s licensees to the Queen et al. patents of $0.5 million, which consisted of royalties earned on sales of Tysabri®; and |
◦ | Interest revenue from note receivable investment to CareView Communications (“CareView”) of $0.8 million. |
• | Total revenues for the third quarter of 2018 were $67.9 million, compared with $62.7 million for the third quarter of 2017, reflecting PDL’s strategic shift to a pharmaceutical business model. |
◦ | Product revenue was $24.4 million, a 22% increase from $20.1 million for the comparable prior-year quarter due to sales of the Noden Products and the LENSAR Laser System, the latter of which PDL did not begin to recognize until May 2017. Product revenues accounted for 36% of total revenues compared with 32% in the third quarter of 2017; |
◦ | Product revenue from the Noden Products was $9.7 million in the U.S. and $8.1 million in the rest of the world; |
◦ | PDL recognized $42.2 million in revenue from royalty rights - change in fair value, compared with $35.4 million in the prior-year period. The increase was due to the increased fair value of the Assertio royalty rights as a result of the purchase of all of Assertio’s remaining interest in royalty and milestone payments payable on sales of type 2 diabetes products licensed by Assertio, offset by declines in fair value adjustments for certain other royalty right assets; |
▪ | PDL received $19.1 million in net cash royalties from its royalty rights for the third quarter of 2018, compared with $26.3 million for the prior-year period. The decrease is mainly due to higher royalties in 2017 as a result of the launch of the authorized generic for Glumetza® in February 2017 sold by a subsidiary of Bausch Health Companies Inc. (formerly known as Valeant Pharmaceuticals International, Inc.); |
◦ | Royalties from PDL’s licensees to the Queen et al. patents were $0.5 million, compared with $1.4 million for the third quarter of 2017 as product supply of Tysabri® manufactured prior to patent expiry in the U.S. have been extinguished and ex-U.S. product supplies are rapidly being depleted; and |
◦ | Interest revenue from the note receivable investment to CareView was $0.8 million. Interest revenue decreased from $5.3 million in the prior-year due to the sale of the kaléo, Inc. note receivable in September 2017. |
• | Total revenues for the nine months ended September 30, 2018 were $153.0 million, compared with $252.0 million for the nine months ended September 30, 2017: |
◦ | Product revenue was $79.5 million, a 54% increase from $51.5 million for the prior-year period. Product revenue for 2018 consisted of $62.0 million from sales of the Noden Products and $17.5 million from sales of the LENSAR® Laser System; |
◦ | PDL recognized $66.1 million in revenue from royalty rights - change in fair value, compared with $132.2 million for the prior-year period; |
▪ | PDL received $57.0 million in net cash royalties from its royalty rights year-to-date 2018, compared with $74.4 million for the prior-year period; |
◦ | Royalties from PDL’s licensees to the Queen et al. patents were $4.5 million, compared with $31.9 million for the prior-year period; and |
◦ | Interest revenue from note receivable investment to CareView was $2.3 million. Interest revenue decreased from $17.0 million in the comparable nine-month period of 2017 due to the above-noted sale of the kaléo, Inc. note receivable in September 2017. |
◦ | License and other revenue decreased by $18.9 million primarily due to a $19.5 million payment received in 2017 from Merck as part of the previously announced settlement agreement to resolve the patent infringement lawsuits related to Keytruda®. |
• | Operating expenses for the three months ended September 30, 2018 of $31.2 million increased $1.0 million from $30.1 million for the three months ended September 30, 2017. The increase was a result of the Noden Products and LENSAR contributing additional cost of product revenue of $6.0 million and $0.4 million, respectively, due to increased revenue from the Noden Products and recognition of costs of product revenue for ex-U.S. revenue and increased revenue from LENSAR, as well as general and administrative expenses increasing 10%, or $1.2 million, primarily due to stock-based compensation awards granted in the period, partially offset by lower asset management and asset purchase professional expenses. The increase in operating expenses was partially offset by lower intangible asset amortization expense due to the second quarter of 2018 impairment of the intangible assets related to the Noden Products, as well as by reduced sales and marketing expenses related to the change in marketing strategy of the Noden Products. |
• | Operating expenses for the nine months ended September 30, 2018 were $237.1 million, a $149.0 million increase from $88.1 million for the prior-year period. The increase was primarily a result of the impairment of the Noden intangible asset of $152.3 million, as well as the Noden Products and LENSAR contributing additional cost of product revenue of $20.0 million and $4.4 million, respectively, which was due to increased revenue from the Noden Products and recognition of costs of product revenue for ex-U.S. revenue and increased revenue from LENSAR, which PDL did not begin to recognize until May 2017, partially offset by the decrease in fair value of the contingent liability. |
• | From July 1, 2018 to July 5, 2018, the Company completed its $25.0 million stock repurchase program with the repurchase of 0.6 million shares of its common stock at a weighted average price of $2.44 per share, for a total of $1.4 million. |
• | PDL repurchased 8.7 million shares of its common stock under the $25.0 million share repurchase program during the nine months ended September 30, 2018, for an aggregate purchase price of $25.0 million, or an average cost of $2.86 per share, including trading commission. All shares repurchased were retired. |
• | Since initiating its first stock repurchase program in March 2017, the Company has used $55.0 million to repurchase a total of 22.1 million shares of its common stock. |
• | On September 21, 2018, the Company’s board of directors authorized the repurchase of issued and outstanding shares of the Company’s common stock having an aggregate value of up to $100.0 million pursuant to a new share repurchase program. |
• | PDL had cash and cash equivalents of $401.0 million as of September 30, 2018, compared with cash, cash equivalents and short-term investments of $532.1 million as of December 31, 2017. |
• | The reduction in cash balance for the nine months ended September 30, 2018 was primarily a result of retiring the remaining $126.4 million of principal from PDL’s 4.0% Convertible Senior Notes due 2018, plus $2.6 million of accrued interest, common stock repurchases of $25.0 million and the $20.0 million purchase of Assertio’s remaining interest in royalty and milestone payments payable on sales of type 2 diabetes products licensed by Assertio, partially offset by the proceeds from royalty rights of $57.0 million. |
Three Months Ended | Nine Months Ended | |||||||||||||||
September 30, | September 30, | |||||||||||||||
2018 | 2017 | 2018 | 2017 | |||||||||||||
Revenues | ||||||||||||||||
Royalties from Queen et al. patents | $ | 533 | $ | 1,443 | $ | 4,534 | $ | 31,884 | ||||||||
Royalty rights - change in fair value | 42,184 | 35,353 | 66,117 | 132,224 | ||||||||||||
Interest revenue | 754 | 6,051 | 2,254 | 16,968 | ||||||||||||
Product revenue, net | 24,387 | 20,067 | 79,472 | 51,477 | ||||||||||||
License and other | 40 | (165 | ) | 614 | 19,471 | |||||||||||
Total revenues | 67,898 | 62,749 | 152,991 | 252,024 | ||||||||||||
Operating Expenses | ||||||||||||||||
Cost of product revenue (excluding intangible amortization and impairment) | 11,926 | 5,565 | 37,016 | 12,632 | ||||||||||||
Amortization of intangible assets | 1,577 | 6,275 | 14,254 | 18,438 | ||||||||||||
General and administrative expenses | 13,211 | 11,989 | 39,401 | 35,853 | ||||||||||||
Sales and marketing | 3,469 | 4,994 | 14,367 | 11,194 | ||||||||||||
Research and development | 672 | 605 | 2,149 | 6,652 | ||||||||||||
Impairment of intangible assets | — | — | 152,330 | — | ||||||||||||
Change in fair value of anniversary payment and contingent consideration | 302 | 700 | (22,433 | ) | 3,349 | |||||||||||
Total operating expenses | 31,157 | 30,128 | 237,084 | 88,118 | ||||||||||||
Operating income (loss) | 36,741 | 32,621 | (84,093 | ) | 163,906 | |||||||||||
Non-operating expense, net | ||||||||||||||||
Interest and other income, net | 1,581 | 238 | 4,871 | 726 | ||||||||||||
Interest expense | (2,866 | ) | (5,096 | ) | (9,262 | ) | (15,082 | ) | ||||||||
Gain (loss) on bargain purchase | — | (2,276 | ) | — | 3,995 | |||||||||||
Total non-operating expense, net | (1,285 | ) | (7,134 | ) | (4,391 | ) | (10,361 | ) | ||||||||
Income (loss) before income taxes | 35,456 | 25,487 | (88,484 | ) | 153,545 | |||||||||||
Income tax expense (benefit) | 9,900 | 4,755 | (3,346 | ) | 65,180 | |||||||||||
Net income (loss) | 25,556 | 20,732 | (85,138 | ) | 88,365 | |||||||||||
Less: Net loss attributable to noncontrolling interests | — | — | — | (47 | ) | |||||||||||
Net income (loss) attributable to PDL’s shareholders | $ | 25,556 | $ | 20,732 | $ | (85,138 | ) | $ | 88,412 | |||||||
Net income (loss) per share | ||||||||||||||||
Basic | $ | 0.18 | $ | 0.14 | $ | (0.58 | ) | $ | 0.56 | |||||||
Diluted | $ | 0.18 | $ | 0.14 | $ | (0.58 | ) | $ | 0.56 | |||||||
Shares used to compute income per basic share | 143,171 | 151,146 | 147,159 | 156,802 | ||||||||||||
Shares used to compute income per diluted share | 144,224 | 152,317 | 147,159 | 157,529 |
September 30, | December 31, | |||||||
2018 | 2017 | |||||||
Cash, cash equivalents and short-term investments | $ | 400,984 | $ | 532,114 | ||||
Total notes receivable | $ | 70,966 | $ | 70,737 | ||||
Total royalty rights - at fair value | $ | 378,291 | $ | 349,223 | ||||
Total assets | $ | 984,427 | $ | 1,243,123 | ||||
Total convertible notes payable | $ | 122,780 | $ | 243,481 | ||||
Total stockholders’ equity | $ | 739,387 | $ | 845,890 |
A reconciliation between net income (loss) on a GAAP basis and on a non-GAAP basis is as follows: | ||||||||||||||||
Three Months Ended | Nine Months Ended | |||||||||||||||
September 30, | September 30, | |||||||||||||||
2018 | 2017 | 2018 | 2017 | |||||||||||||
GAAP net income (loss) attributed to PDL’s shareholders as reported | $ | 25,556 | $ | 20,732 | $ | (85,138 | ) | $ | 88,412 | |||||||
Adjustments to Non-GAAP net income (loss) (as detailed below) | (13,249 | ) | 975 | 126,925 | (14,730 | ) | ||||||||||
Non-GAAP net income attributed to PDL’s shareholders | $ | 12,307 | $ | 21,707 | $ | 41,787 | $ | 73,682 | ||||||||
An itemized reconciliation between net income (loss) on a GAAP basis and on a non-GAAP basis is as follows: | ||||||||||||||||
Three Months Ended | Nine Months Ended | |||||||||||||||
September 30, | September 30, | |||||||||||||||
2018 | 2017 | 2018 | 2017 | |||||||||||||
GAAP net income (loss) attributed to PDL’s shareholders as reported | $ | 25,556 | $ | 20,732 | $ | (85,138 | ) | $ | 88,412 | |||||||
Adjustments: | ||||||||||||||||
Mark-to-market adjustment to fair value assets | (23,128 | ) | (9,011 | ) | (9,068 | ) | (57,820 | ) | ||||||||
Non-cash interest revenues | (79 | ) | (670 | ) | (229 | ) | (823 | ) | ||||||||
Non-cash stock-based compensation expense | 2,596 | 939 | 4,814 | 3,014 | ||||||||||||
Non-cash debt offering costs | 1,834 | 2,801 | 5,745 | 8,195 | ||||||||||||
Mark-to-market adjustment on warrants held | (40 | ) | 165 | (114 | ) | 29 | ||||||||||
Impairment of intangible assets | — | — | 152,330 | — | ||||||||||||
Amortization of intangible assets | 1,577 | 6,275 | 14,254 | 18,438 | ||||||||||||
Mark-to-market adjustment of anniversary payment and contingent consideration | 302 | 700 | (22,433 | ) | 3,349 | |||||||||||
Income tax effect related to above items | 3,689 | (224 | ) | (18,374 | ) | 10,888 | ||||||||||
Total adjustments | (13,249 | ) | 975 | 126,925 | (14,730 | ) | ||||||||||
Non-GAAP net income | $ | 12,307 | $ | 21,707 | $ | 41,787 | $ | 73,682 |
• | Total revenues of $67.9 million. |
• | GAAP net income attributable to PDL’s shareholders of $25.6 million or $0.18 per share. |
• | Non-GAAP net income attributable to PDL’s shareholders of $12.3 million. |
• | Cash and cash equivalents of $401.0 million as of September 30, 2018. |
• | Acquired all of Assertio Therapeutic’s (formerly known as Depomed) remaining rights to royalties and milestones payable on sales of type 2 diabetes products for $20 million. |
• | Completed a $25.0 million share repurchase program authorized in September 2017 by repurchasing 0.6 million shares of common stock in the open market during the quarter for $1.4 million in July 2018. |
• | Announced new share repurchase program of up to $100.0 million. |
• | CEO Succession Plan |
• | Stock Repurchase Programs |
• | Depomed Royalty Rights |
• | Noden US is commercializing Tekturna® and Tekturna HCT® in the United States and Noden Pharma DAC, an Ireland based company, assumed commercialization responsibilities for Rasilez® and Rasilez HCT® in the rest of the world, starting in November of 2017. The products are indicated for the treatment of hypertension. |
• | Noden and PDL are evaluating additional pharma products to acquire for Noden. |
• | Noden net revenue for the quarter ended September 30, 2018 was $17.8 million, with $9.7 million in US revenue and $8.1 million in the rest of world, compared to $15.1 million for the same period in 2017. |
• | Noden product revenues increased 18 percent and accounted for approximately 26 percent of total revenues compared to approximately 24 percent in the third quarter of 2017. |
• | Gross margins on revenue in the third quarter were 56 percent, 83 percent in the U.S. on Tekturna and Tekturna HCT and 24 percent ex-U.S. on Rasilez and Rasilez HCT. |
• | In June 2018, Noden Pharma DAC entered into a settlement agreement with Anchen Pharmaceuticals, Inc. and its affiliates to resolve the patent litigation relating to Anchen’s Abbreviated New Drug Application (“ANDA”) seeking approval from the U.S. Food and Drug Administration (“FDA”) to market a generic version of aliskiren. Under the settlement agreement, Anchen agreed to not commercialize its generic version of aliskiren prior to March 1, 2019, but is not permitted to commercialize a copy of Tekturna. Anchen is the sole ANDA filer for aliskiren of which the Company is aware. |
• | Due to the increased probability of a generic version of aliskiren being launched in the United States in 2019. Noden determined that long-lived assets with a carrying amount of $192.5 million were impaired and wrote them down to their estimated fair value of $40.1 million, resulting in a non-cash pre-tax impairment charge of $152.3 million in the second quarter of 2018. This write-down is included in “Impairment of intangible asset” on the Condensed Consolidated Statement of Income for the nine months ended September 30, 2018. |
• | As of September 30, 2018, the remaining balance of Noden Products intangible assets is $38.9 million and is being amortized straight-line over the remaining life of 8 years. |
• | Offsetting the impairment was a $22.5 million decrease in fair value of the contingent liability related to the reduced estimate in the probability in paying milestones to Novartis for Tekturna. |
• | There is no update on Anchen’s progress in developing a generic Tekturna but, there has yet to be an FDA approval of a generic version of the drug and there have been no announcements on commercialization plans or dates. |
• | LENSAR Laser System revenue for the quarter ended September 30, 2018 was $6.6 million compared to $5.0 million for the quarter ended September 30, 2017. |
• | Gross margins on LENSAR revenue in the third quarter were 38 percent. |
Fair Value as of | Purchase of | Royalty Rights - | Fair Value as of | |||||||||||||
(in thousands) | December 31, 2017 | Royalty Assets | Change in Fair Value | September 30, 2018 | ||||||||||||
Assertio (formerly Depomed) | $ | 232,038 | $ | 20,000 | $ | 13,665 | $ | 265,703 | ||||||||
VB | 14,380 | — | (494 | ) | 13,886 | |||||||||||
U-M | 26,769 | — | 755 | 27,524 | ||||||||||||
AcelRx | 72,894 | — | (4,619 | ) | 68,275 | |||||||||||
Avinger | 396 | — | (396 | ) | — | |||||||||||
KYBELLA | 2,746 | — | 157 | 2,903 | ||||||||||||
$ | 349,223 | $ | 20,000 | $ | 9,068 | $ | 378,291 |
Three Months Ended | ||||||||||||
September 30, 2018 | ||||||||||||
Change in | Royalty Rights - | |||||||||||
(in thousands) | Cash Royalties | Fair Value | Change in Fair Value | |||||||||
Assertio (formerly Depomed) | $ | 17,482 | $ | 31,631 | $ | 49,113 | ||||||
VB | 277 | (779 | ) | (502 | ) | |||||||
U-M | 1,152 | 1,375 | 2,527 | |||||||||
AcelRx | 70 | (9,158 | ) | (9,088 | ) | |||||||
KYBELLA | 77 | 57 | 134 | |||||||||
$ | 19,058 | $ | 23,126 | $ | 42,184 |
Nine Months Ended | ||||||||||||
September 30, 2018 | ||||||||||||
Change in | Royalty Rights - | |||||||||||
(in thousands) | Cash Royalties | Fair Value | Change in Fair Value | |||||||||
Assertio (formerly Depomed) | $ | 52,077 | $ | 13,665 | $ | 65,742 | ||||||
VB | 820 | (494 | ) | 326 | ||||||||
U-M | 3,437 | 755 | 4,192 | |||||||||
AcelRx | 190 | (4,619 | ) | (4,429 | ) | |||||||
Avinger | 366 | (396 | ) | (30 | ) | |||||||
KYBELLA | 159 | 157 | 316 | |||||||||
$ | 57,049 | $ | 9,068 | $ | 66,117 |
• | Glumetza (and authorized generic version) royalty: 50% of net sales less COGS continue so long as the products are being commercialized. |
• | Low to mid-single digit royalties to PDL on new product approvals expected to continue to 2023 for Invokamet XR® US, 2026 for Jentadueto XR® and Synjardy XR®, and 2027 for Invokamet XR® ex-US. |
• | The Queen et al. patents have expired and the resulting royalty revenue has dropped substantially since the first quarter of 2016. We continue to receive royalty revenue from one product under the Queen et al. patent licenses, Tysabri, as a result of sales of the product that was manufactured prior to patent expiry. |
• | PDL recorded revenue of $0.5 million from Tysabri in Q3 2018. |
• | Royalties from PDL’s licensees to the Queen et al. patents were $0.9 million lower than in the third quarter of 2017 as product supply of Tysabri manufactured prior to patent expiry in the United States have been extinguished and ex-U.S. product supplies are rapidly being exhausted. As a result, we expect royalties from product sales of Tysabri to cease in the fourth quarter of 2018. |
September 30, 2018 | December 31, 2017 | |||||||||||||||
(In thousands) | Carrying Value | Fair Value Level 3 | Carrying Value | Fair Value Level 3 | ||||||||||||
Wellstat Diagnostics note receivable | $ | 50,191 | $ | 59,881 | $ | 50,191 | $ | 51,308 | ||||||||
Hyperion note receivable | 1,200 | 1,200 | 1,200 | 1,200 | ||||||||||||
CareView note receivable | 19,575 | 19,723 | 19,346 | 18,750 | ||||||||||||
$ | 70,966 | $ | 80,804 | $ | 70,737 | $ | 71,258 |
Queen et al. Royalties | ||||||||||
Royalty Revenue by Product ($ in 000's) * | ||||||||||
Tysabri | Q1 | Q2 | Q3 | Q4 | Total | |||||
2018 | 2,783 | 1,218 | 533 | — | 4,534 | |||||
2017 | 14,156 | 16,284 | 1,443 | 4,531 | 36,414 | |||||
2016 | 13,970 | 14,232 | 14,958 | 15,513 | 58,673 | |||||
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. |
Queen et al. Sales Revenue | ||||||||||
Reported Licensee Net Sales Revenue by Product ($ in 000's) * | ||||||||||
Tysabri | Q1 | Q2 | Q3 | Q4 | Total | |||||
2018 | 92,769 | 40,602 | 17,738 | — | 151,109 | |||||
2017 | 471,877 | 398,382 | 194,563 | 177,379 | 1,242,201 | |||||
2016 | 465,647 | 474,379 | 498,618 | 517,099 | 1,955,743 | |||||
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. |