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 | Jennifer Williams | |
PDL BioPharma, Inc. | Cook Williams Communications, Inc. | |
775-832-8500 | 360-668-3701 | |
Peter.Garcia@pdl.com | jennifer@cwcomm.org |
• | Total revenues of $38.5 million for the three months ended March 31, 2018. |
• | GAAP diluted EPS of $0.01 for the three months ended March 31, 2018. |
• | GAAP net income attributable to PDL’s shareholders of $1.6 million for the three months ended March 31, 2018. |
• | Non-GAAP net income attributable to PDL’s shareholders of $13.4 million for the three months ended March 31, 2018. A full reconciliation of all components of the GAAP to non-GAAP financial results can be found in Table 3 at the end of the release. |
• | Total revenues of $38.5 million for the three months ended March 31, 2018 included: |
◦ | Product revenues of $23.3 million, which consisted of $18.3 million from sales of Tekturna® and Tekturna HCT® in the United States, Rasilez® and Rasilez HCT® in the rest of the world (collectively, the Noden Products) and $5.0 million for product sales of the LENSAR® Laser System; |
◦ | Net royalty payments from acquired royalty rights and a change in fair value of the royalty rights assets of $11.1 million, which consisted of the change in estimated fair value of our royalty right assets, primarily related to the Depomed royalty asset; |
◦ | Royalties from PDL’s licensees to the Queen et al. patents of $2.8 million, which consisted of royalties earned on sales of Tysabri®; and |
◦ | Interest revenue from note receivable investment to CareView Communications of $0.7 million. |
• | Total revenues decreased by 15 percent or $6.9 million for the three months ended March 31, 2018, when compared to the same period in 2017. The evolution of our revenues reflects PDL’s strategic shift to a specialty biopharmaceutical business model and the residual decline in royalty income from our expired Queen et al. patents. |
◦ | The 85 percent increase in product revenues was derived from the 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 approximately 61 percent of total revenues compared to approximately 28 percent in the first quarter of 2017. Rasilez and Rasilez HCT revenues were $7.8 million, which was the first full quarter of revenue recognized from the ex-U.S. commercialization by Noden, having assumed commercialization from Novartis in November 2017; |
◦ | PDL received $18.6 million in net cash royalties from its royalty rights in the first quarter of 2018, compared to $13.5 million for the same period of 2017. The increase in cash royalties is mainly due to royalties from Glumetza® sold by Valeant Pharmaceuticals International, Inc., partially offset by the decrease of royalties from ARIAD Pharmaceuticals, Inc. as royalties ceased when the asset was sold in the first quarter of 2017; |
◦ | Royalties from PDL’s licensees to the Queen et al. patents were 80 percent or $11.4 million lower than in the first 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; and |
◦ | The decrease in interest revenues was primarily due to the sale of the kaléo, Inc. note receivable in September 2017. |
• | Operating expenses were $34.2 million for the three months ended March 31, 2018, compared to $26.9 million for the same period of 2017. The increase in operating expenses for the three months ended March 31, 2018, as compared to the same period in 2017, was primarily a result of Noden Products and LENSAR contributing additional cost of product revenue of $5.6 million and $2.4 million, respectively, which was the result of increased revenue and recognition of costs of goods for ex-U.S. revenue from Noden Products and increased revenue from LENSAR, which PDL did not begin to recognize until May 2017. Sales and marketing expenses at Noden and LENSAR increased an additional $1.4 million and $1.5 million, respectively, and research and development expenses increased an additional $0.6 million due to LENSAR clinical studies. These increases were partially offset by a decrease in the fair value of acquisition-related contingent consideration of $2.0 million, a decrease in research and development costs for the completion of a pediatric trial for Tekturna and a decrease in general and administration asset management and legal expenses related to the Merck litigation. |
• | From April 1, 2018 to May 8, 2018, the Company repurchased approximately 2.8 million shares of its common stock under the share repurchase program at a weighted average price of $3.03 per share for a total of $8.4 million. |
• | Since the inception of the share repurchase program in March 2018, the Company has repurchased approximately 4.2 million shares of its common stock for a total of $12.6 million. |
• | Approximately $12.4 million remains available under the current share repurchase program. |
• | PDL had cash, cash equivalents, short-term investments and other investments of $405.1 million at March 31, 2018, compared to $532.1 million at December 31, 2017. The change in cash balance for the quarter was primarily a result of PDL retiring the remaining $126.4 million of principal of its 4.0% Convertible Senior Notes due 2018 at their stated maturity by making a payment to the noteholders of $129.0 million, which included $2.6 million of accrued interest. |
Three Months Ended | ||||||||
March 31, | ||||||||
2018 | 2017 | |||||||
Revenues | ||||||||
Royalties from Queen et al. patents | $ | 2,783 | $ | 14,156 | ||||
Royalty rights - change in fair value | 11,091 | 13,146 | ||||||
Interest revenue | 749 | 5,457 | ||||||
Product revenue, net | 23,324 | 12,581 | ||||||
License and other | 571 | 100 | ||||||
Total revenues | 38,518 | 45,440 | ||||||
Operating Expenses | ||||||||
Cost of product revenue (excluding intangible amortization) | 10,566 | 2,552 | ||||||
Amortization of intangible assets | 6,293 | 6,015 | ||||||
General and administrative expenses | 11,661 | 12,576 | ||||||
Sales and marketing | 5,513 | 2,584 | ||||||
Research and development | 793 | 1,766 | ||||||
Change in fair value of anniversary payment and contingent consideration | (600 | ) | 1,442 | |||||
Total operating expenses | 34,226 | 26,935 | ||||||
Operating income | 4,292 | 18,505 | ||||||
Non-operating expense, net | ||||||||
Interest and other income, net | 1,914 | 212 | ||||||
Interest expense | (3,585 | ) | (4,971 | ) | ||||
Total non-operating expense, net | (1,671 | ) | (4,759 | ) | ||||
Income before income taxes | 2,621 | 13,746 | ||||||
Income tax expense | 1,019 | 6,552 | ||||||
Net income | 1,602 | 7,194 | ||||||
Less: Net income/(loss) attributable to noncontrolling interests | — | (47 | ) | |||||
Net income attributable to PDL’s shareholders | $ | 1,602 | $ | 7,241 | ||||
Net income per share | ||||||||
Basic | $ | 0.01 | $ | 0.04 | ||||
Diluted | $ | 0.01 | $ | 0.04 | ||||
Shares used to compute income per basic share | 151,473 | 163,745 | ||||||
Shares used to compute income per diluted share | 152,579 | 163,992 | ||||||
Cash dividends declared per common share | $ | — | $ | — |
March 31, | December 31, | |||||||
2018 | 2017 | |||||||
Cash, cash equivalents and short-term investments | $ | 405,078 | $ | 532,114 | ||||
Total notes receivable | $ | 70,811 | $ | 70,737 | ||||
Total royalty rights - at fair value | $ | 341,691 | $ | 349,223 | ||||
Total assets | $ | 1,100,401 | $ | 1,243,123 | ||||
Total convertible notes payable | $ | 119,166 | $ | 243,481 | ||||
Total stockholders’ equity | $ | 843,109 | $ | 845,890 |
A reconciliation between net income on a GAAP basis and on a non-GAAP basis is as follows: | ||||||||
Three Months Ended | ||||||||
March 31, | ||||||||
2018 | 2017 | |||||||
GAAP net income attributed to PDL’s shareholders as reported | $ | 1,602 | $ | 7,241 | ||||
Adjustments to Non-GAAP net income (as detailed below) | 11,776 | 5,971 | ||||||
Non-GAAP net income attributed to PDL’s shareholders | $ | 13,378 | $ | 13,212 | ||||
An itemized reconciliation between net income on a GAAP basis and on a non-GAAP basis is as follows: | ||||||||
Three Months Ended | ||||||||
March 31, | ||||||||
2018 | 2017 | |||||||
GAAP net income attributed to PDL’s shareholders as reported | $ | 1,602 | $ | 7,241 | ||||
Adjustments: | ||||||||
Mark-to-market adjustment to fair value assets | 7,532 | 348 | ||||||
Non-cash interest revenues | (74 | ) | (75 | ) | ||||
Non-cash stock-based compensation expense | 957 | 1,112 | ||||||
Non-cash debt offering costs | 2,132 | 2,675 | ||||||
Mark-to-market adjustment on warrants held | (71 | ) | (100 | ) | ||||
Amortization of the intangible assets | 6,293 | 6,015 | ||||||
Mark-to-market adjustment of anniversary payment and contingent consideration | (600 | ) | 1,442 | |||||
Income tax effect related to above items | (4,393 | ) | (5,446 | ) | ||||
Total adjustments | 11,776 | 5,971 | ||||||
Non-GAAP net income | $ | 13,378 | $ | 13,212 |
• | Total revenues of $38.5 million for the three months ended March 31, 2018. |
• | GAAP diluted EPS of $0.01 for the three months ended March 31, 2018. |
• | GAAP net income attributable to PDL’s shareholders of $1.6 million for the three months ended March 31, 2018. |
• | Non-GAAP net income attributable to PDL’s shareholders of $13.4 million for the three months ended March 31, 2018. |
• | PDL had cash, cash equivalents, short-term investments and other investments of $405.1 million at March 31, 2018, compared to $532.1 million at December 31, 2017. The change in cash balance for the quarter was primarily a result of PDL retiring the remaining $126.4 million of principal of its 4.0% Convertible Senior Notes due 2018 at their stated maturity by making a payment to the noteholders of $129.0 million, which included $2.6 million of accrued interest. |
• | On March 31, 2018, PDL had a net book value of approximately $5.60 per share. |
• | From April 1, 2018 to May 8, 2018, the Company repurchased approximately 2.8 million shares of its common stock under the share repurchase program at a weighted average price of $3.03 per share for a total of $8.4 million. |
• | Since the inception of the share repurchase program in March 2018, the Company has repurchased approximately 4.2 million shares of its common stock for a total of $12.6 million. |
• | Approximately $12.4 million remains available under the current share repurchase program. |
• | 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. |
• | PDL owns 100 percent of Noden and continues to hold three of five board seats. |
• | Noden and PDL are evaluating additional pharma products in the form of optimized, established medicines, to acquire for Noden. |
• | Noden net revenue for the quarter ended March 31, 2018 was $18.3 million, with $10.5 million in US revenue and $7.8 million in the rest of world, compared to $12.6 for the same period in 2017. |
◦ | Noden product revenues increased 46 percent and accounted for approximately 61 percent of total revenues compared to approximately 28 percent in the first quarter of 2017. |
◦ | Rasilez and Rasilez HCT revenues were $7.8 million, which was the first full quarter of revenue recognized from the ex-U.S. commercialization by Noden, having assumed commercialization from Novartis in November 2017; |
◦ | Gross margins on revenue in the first quarter were 55.4 percent, 80 percent in the U.S. on Tekturna and Tekturna HCT and 24 percent ex-U.S. on Rasilez and Rasilez HCT. |
◦ | Noden’s overall goal is to maximize profits generated from its portfolio, and this led us to de-register the products in those few European countries where Rasilez was either not or only marginally profitable. Although this has had a negative impact on revenue, it has improved operating margins. |
• | In December of 2017, Noden entered into an agreement with Lee’s Pharmaceutical Holdings Ltd. granting them exclusive sales rights to Rasilez in China, Hong Kong, Macau and Taiwan, with guaranteed payments due to Noden. We had not forecasted sales in these territories during our acquisition of Rasilez, so this agreement represents an incremental opportunity. |
• | Also in December, 2017, Noden entered into an agreement with Orphan Pacific for the distribution of Rasilez in Japan. The marketing authorization has been transferred from Novartis, and Orphan Pacific started shipping products in the Japanese market at the end of February, 2018. |
• | LENSAR Laser System revenue for the for the quarter ended March 31, 2018 was $5.0 million. PDL did not begin recognizing revenue from LENSAR until May 2017. |
• | Gross margins on LENSAR revenue in the first quarter were 52.2 percent. |
Fair Value as of | Royalty Rights - | Fair Value as of | ||||||||||
(in thousands) | December 31, 2017 | Change in Fair Value | March 31, 2018 | |||||||||
Depomed | $ | 232,038 | $ | (9,430 | ) | $ | 222,608 | |||||
VB | 14,380 | 137 | 14,517 | |||||||||
U-M | 26,769 | (187 | ) | 26,582 | ||||||||
AcelRx | 72,894 | 2,237 | 75,131 | |||||||||
Avinger | 397 | (295 | ) | 102 | ||||||||
KYBELLA | 2,745 | 6 | 2,751 | |||||||||
$ | 349,223 | $ | (7,532 | ) | $ | 341,691 |
Change in | Royalty Rights - | |||||||||||
(in thousands) | Cash Royalties | Fair Value | Change in Fair Value | |||||||||
Depomed | $ | 16,907 | $ | (9,430 | ) | $ | 7,477 | |||||
VB | 280 | 137 | 417 | |||||||||
U-M | 996 | (187 | ) | 809 | ||||||||
AcelRx | 52 | 2,237 | 2,289 | |||||||||
Avinger | 305 | (295 | ) | 10 | ||||||||
KYBELLA | 83 | 6 | 89 | |||||||||
$ | 18,623 | $ | (7,532 | ) | $ | 11,091 |
• | 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® and 2026 for Jentadueto XR® and Synjardy XR®. |
• | While 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. |
• | Royalties from PDL’s licensees to the Queen et al. patents were 80 percent or $11.4 million lower than in the first 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. |
• | PDL recorded revenue of $2.8 million from Tysabri in Q1 2018. |
March 31, 2018 | December 31, 2017 | ||||||||||||||||
(In thousands) | Carrying Value | Fair Value Level 3 | Carrying Value | Fair Value Level 3 | |||||||||||||
Wellstat Diagnostics note receivable | $ | 50,191 | $ | 52,412 | $ | 50,191 | $ | 51,308 | |||||||||
Hyperion note receivable | 1,200 | 1,200 | 1,200 | 1,200 | 1,200 | ||||||||||||
CareView note receivable | 19,245 | 19,420 | 19,100 | 19,346 | 18,750 | ||||||||||||
$ | 70,811 | $ | 72,712 | $ | 70,737 | $ | 71,258 |
• | In February 2018, we entered into a modification agreement with CareView whereby we agreed, effective as of December 28, 2017, to modify the credit agreement before remedies could otherwise have become available to us under the credit agreement in relation to certain obligations of CareView that would potentially not be met, including the requirement to make principal payments. Under the modification agreement we agreed that (i) a lower liquidity covenant would be applicable and (ii) principal repayment would be delayed for a period of up to December 31, 2018. In exchange for agreeing to these modifications, among other things, the exercise price of our warrants to purchase 4.4 million shares of common stock of CareView was reduced and, subject to the occurrence of certain events, CareView agreed to grant us additional equity interests. |
• | In NY court action commenced by PDL to collect from related entities who are guarantors of the loan, the judge ruled in favor of PDL. On appeal, the appellate division of the NY court reversed on procedural grounds the portion of the decision granting PDL summary judgment, remanding the case to the trial division for a plenary action. The action is currently before the NY trial court and in the pre-trial phase. The parties will have the opportunity to conduct discovery and file dispositive motions prior to trial. No trial date has been set yet. |
• | In September 2017, Wellstat Therapeutics, one of the Wellstat Guarantors, obtained a decision against BTG International, Inc. in a breach of contract case which set the damages at $55.8 million plus interest and fees. Wellstat Therapeutics will only receive the award in a final court decision or settlement between the parties, and BTG has appealed the decision. |
• | On February 6, 2018, the NY Court issued an order from the bench which enjoins the Wellstat Diagnostics Guarantors from selling, encumbering, removing, transferring or altering the collateral, and further precludes PDL from foreclosing on certain collateral during the pendency of the case. |
Queen et al. Royalties | ||||||||||
Royalty Revenue by Product ($ in 000's) * | ||||||||||
Tysabri | Q1 | Q2 | Q3 | Q4 | Total | |||||
2018 | 2,783 | — | — | — | 2,783 | |||||
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 | — | — | — | 92,769 | |||||
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. |