On March 8, 2018 Progenics Pharmaceuticals, Inc. (Nasdaq:PGNX) reported financial results and provided a business update for the fourth quarter and full-year 2017 (Press release, Progenics Pharmaceuticals, MAR 8, 2018, View Source [SID1234524570]).

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"2017 was a year of strong progress for our targeted oncology pipeline programs, capped by the FDA’s acceptance for review of the New Drug Application (NDA) for AZEDRA," said Mark Baker, Chief Executive Officer of Progenics. "AZEDRA has the potential to be a transformative treatment option for patients with malignant, recurrent, and/or unresectable pheochromocytoma and paraganglioma, rare and life-threatening neuroendocrine tumors for which there are no approved therapies in the U.S. As we approach the FDA’s action date, we are readying our commercial organization for launch upon potential approval."

Mr. Baker continued, "We also continue to build momentum in advancing our development-stage PSMA-targeted radiopharmaceutical programs, which are designed to find, fight and follow prostate cancer. We have completed enrollment in our Phase 3 study for 1404, with results anticipated in the third quarter, and we expect to complete our current Phase 2/3 study for PyL in the second half of this year."

Fourth Quarter and Recent Key Business Highlights

AZEDRA, Ultra-orphan radiotherapeutic candidate

Action Date for AZEDRA New Drug Application (NDA) Set for April 30th
In December 2017, Progenics announced that the FDA accepted for review the NDA for AZEDRA in patients with malignant, recurrent, and/or unresectable pheochromocytoma and paraganglioma, rare neuroendocrine tumors for which there are currently no approved treatment options in the U.S. The FDA granted Progenics’ request for Priority Review and has set an action date of April 30, 2018 under the Prescription Drug User Fee Act (PDUFA). AZEDRA holds Breakthrough Therapy designation and Orphan Drug status, as well as Fast Track designation.
Clinical Data from Pivotal Phase 2b AZEDRA Study Presented at Major Medical Meetings
In October 2017, Progenics presented the positive results from its pivotal Phase 2b study evaluating AZEDRA at the North American Neuroendocrine Tumor Society (NANETS) 2017 Annual Symposium and the 30th Annual Congress of the European Association of Nuclear Medicine (EANM). Progenics also plans to present biochemical tumor marker data from this study at the upcoming Endocrine Society (ENDO) Annual Meeting in March 2018.
PSMA-Targeted Prostate Cancer Pipeline

Enrollment Complete in Phase 3 Study of 1404
In January 2018, Progenics announced the completion of enrollment in its Phase 3 study of 1404, a PSMA-targeted small molecule SPECT/CT imaging agent designed to visualize prostate cancer. The study enrolled approximately 450 patients in the U.S. and Canada with newly-diagnosed or low-grade prostate cancer, whose biopsy indicates a histopathologic Gleason grade of ≤ 3+4 severity and/or are candidates for active surveillance. Top-line data is expected in the third quarter of 2018.
Phase 2/3 Study of PyL Ongoing
Progenics continues to enroll patients in the Phase 2/3 study of PyL, a PSMA-targeted PET/CT imaging agent, evaluating diagnostic accuracy in patients with recurrent and/or metastatic prostate cancer. The Company expects to complete enrollment of this study in the second half of 2018 and initiate a second Phase 3 study in patients with biochemical recurrence of prostate cancer.
Enrollment Ongoing in Phase 1 Study for 1095
Progenics continues to enroll patients in the Phase 1 open-label dose escalation study of 1095, a small molecule radiotherapeutic that selectively binds to PSMA, in patients with metastatic castration-resistant prostate cancer (mCRPC) who have demonstrated tumor avidity to 1095.
Initiation of Phase 1 Study for PSMA-TTC Expected in 2018
Progenics expects its partner Bayer to initiate a Phase 1 study of PSMA-Targeted Thorium Conjugate (PSMA-TTC) in patients with mCRPC by year end 2018. Bayer was previously granted exclusive worldwide rights to develop and commercialize products using Progenics’s PSMA antibody technology in combination with Bayer’s alpha-emitting radionuclides.
RELISTOR, treatment for OIC (partnered with Valeant Pharmaceuticals International, Inc.)

RELISTOR Quarterly Net Sales Reached Record Level of $24.6 Million in Q4’17
Full-year 2017 net worldwide sales totaled $73.1 million as reported by our partner, Valeant. The fourth quarter 2017 net sales translated to $3.7 million in royalty revenue for Progenics, while the full year net sales resulted in $11.0 million in royalty revenue. Net sales of RELISTOR grew 44% over the prior quarter.
Fourth Quarter and Full-Year 2017 Financial Results

Fourth quarter 2017 revenue totaled $3.9 million, down from $4.7 million in the fourth quarter of 2016. Revenue for the 2017 period reflects RELISTOR royalty income of $3.7 million compared to $2.4 million in the corresponding period of 2016. The prior year period included milestone revenue of $2.0 million from Bayer for the collaboration of the Company’s PSMA antibody technology in combination with Bayer’s alpha-emitting radionuclides. The full-year 2017 revenue totaled $11.7 million, down from $69.4 million for the full-year of 2016, resulting primarily from the prior year milestone revenue of $50 million for the July 19, 2016 FDA approval of RELISTOR Tablets, and the recognition of $7 million in upfront and development milestone payments from Bayer.

Research and development expenses increased by $0.3 million and $5.0 million in the fourth quarter and full-year 2017, respectively, compared to the corresponding periods in 2016. The full-year increase resulted primarily from higher clinical costs for PyL and higher consulting expenses in preparation for the AZEDRA NDA filing, partially offset by lower clinical costs for AZEDRA. Fourth quarter and full-year general and administrative expenses increased by $2.2 million and $1.6 million, respectively, compared to the corresponding prior periods in 2016, primarily attributable to higher costs associated with building commercial capabilities in preparation for a potential AZEDRA approval and launch. Progenics also recorded non-cash adjustments of ($0.7 million) and $2.6 million in the fourth quarter and full-year 2017, respectively, related to changes in the fair value estimate of the contingent consideration liability. For the three months and year ended December 31, 2017, Progenics recognized interest expense of $1.2 million and $4.8 million, respectively, related to the RELISTOR royalty-backed loan.

In December 2017, the Tax Cuts and Jobs Act (the "Tax Act"), was signed into law. Among other provisions, the Tax Act reduces the U.S. federal statutory corporate income tax rate from 35% to 21% effective for 2018 and provides for an indefinite carryforward period for net operating losses. As a result, the Company recorded an income tax benefit of approximately $11.7 million in 2017, primarily related to the reduction in the federal tax rate and the use of the Company’s deferred tax liability related to indefinite-lived intangible assets (naked tax credit) as a source of income to release a portion of its valuation allowance recorded against deferred tax assets.

Net loss attributable to Progenics for the fourth quarter was $2.7 million or $0.04 per diluted share, compared to a net loss of $7.2 million or $0.10 per diluted share in the corresponding 2016 period. Net loss for the full-year 2017 was $51.0 million or $0.73 per diluted share, compared to net income of $10.8 million or $0.15 per diluted share for the full-year 2016.

Progenics ended the year with cash and cash equivalents of $90.6 million, reflecting a decrease of $7.7 million in the quarter and $48.3 million from 2016 year-end. In order to maintain a strong financial position, in the fourth quarter of 2017 and in January 2018, the Company raised $14.5 million in net proceeds from sales of its common stock under its "at-the-market" (ATM) facility, with $5.0 million received through December 31, 2017 and the remainder received in January.

On March 8, 2018 Valeant Pharmaceuticals International, Inc. (NYSE: VRX and TSX: VRX) ("Valeant") reported that Joseph C. Papa, chairman and chief executive officer, and Arthur J. Shannon, senior vice president and head of Investor Relations and Communications, are scheduled to participate at the Barclays Global Healthcare Conference in Miami on March 14, 2018, at 8:30 a.m. EDT (Press release, Valeant, MAR 8, 2018, http://ir.valeant.com/news-releases/2018/03-08-2018-130427732 [SID1234524572]).

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A live webcast and audio archive of the event will be available on the Investor Relations page of the Valeant web site at: http://ir.valeant.com/events-and-presentations/2018.

On March 8, 2018 Sunesis Pharmaceuticals, Inc. (Nasdaq: SNSS) reported financial results for the fourth quarter and year ended December 31, 2017. Loss from operations for the three months and year ended December 31, 2017 was $6.4 million and $34.4 million, respectively (Press release, Sunesis, MAR 8, 2018, View Source [SID1234524571]). As of December 31, 2017, cash, cash equivalents and marketable securities totaled $31.8 million. This capital is expected to fund the company into early 2019.

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"We are excited about the potential opportunity for our lead program, the non-covalent BTK inhibitor vecabrutinib (SNS-062), to help patients who have developed resistance to covalent BTK inhibitors such as ibrutinib, the current standard of care in treating CLL," said Dayton Misfeldt, Interim Chief Executive Officer of Sunesis. "This year we expect to see our initial safety and efficacy profile for vecabrutinib in its Phase 1b/2 study in patients as we determine the dose to take into our Phase 2 expansion and other studies. Beyond vecabrutinib, we also look forward to advancements in our proprietary PDK1 program and Takeda-partnered pan-RAF inhibitor program."

Recent Highlights

Updates on Phase 1b/2 Study Evaluating Oral Non-Covalent BTK-inhibitor Vecabrutinib (SNS-062) in Adults with Chronic Lymphocytic Leukemia (CLL) and other B-Cell Malignancies. At an investor and analyst event held at the American Society of Hematology (ASH) (Free ASH Whitepaper) Conference in December 2017, Sunesis provided a program update on the ongoing Phase 1b/2 study evaluating the safety, pharmacokinetics, pharmacodynamics, and antitumor activity of its potent non-covalent BTK-inhibitor vecabrutinib in adults with CLL and other B cell malignancies. The Phase 1b/2 trial is an open-label, sequential-group study that is enrolling up to 124 patients who have progressed while on a covalent BTK inhibitor with the goal of determining the maximum tolerated and/or recommended phase 2 dose. We are updating guidance for this program, and now expect to reach a recommended phase 2 dose in the fall of 2018.

Announced Nomination of PDK-1 Inhibitor SNS-510 as Development Candidate. In November 2017, Sunesis announced that its PDK-1 inhibitor, SNS-510, was nominated as a Development Candidate and potentially first-to-clinic selective inhibitor in this pathway. PDK1 is a master kinase that activates other kinases important to cell growth and survival including members of the AKT, PKC, RSK and SGK families.

Changes in Executive Leadership and Board of Directors.

In November 2017, Willie Quinn was appointed Chief Financial Officer and Senior Vice President, Finance and Corporate Development. Prior to joining Sunesis, Willie was CEO and Co-Founder of the private cancer immunotherapy company Bullet Biotechnology. Prior to Bullet Bio, he led Corporate Development and Strategy at Jazz Pharmaceuticals.

In March 2017, Judy Fox, Ph.D. rejoined Sunesis as Chief Scientific Officer. Judy previously served as a Vice President at Sunesis, and has over 25 years of experience with leadership roles at companies including Genentech and Chiron. Her career has focused on

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the translation of basic mechanistic understandings of promising drugs into coherent, evidence-based clinical development. Judy took over as program leader for vecabrutinib in July 2017.

In January 2018, Daniel Swisher stepped down from his role as CEO to pursue another executive opportunity, and the Board of Directors appointed Dayton Misfeldt, a member of the Board since 2009, as Interim CEO, as well as formed a search committee to find a permanent CEO. The search for a permanent CEO is ongoing.

Lastly, in February 2018, H. Ward Wolff was appointed to the Board of Directors. Ward brings over 40 years of finance and executive leadership experience to the Board, with 20 years of experience in the life sciences sector, most recently having served as Executive Vice President and Chief Financial Officer of Sangamo Therapeutics, Inc. Mr. Wolff is also designated chairman of the company’s Audit Committee.

Financial Highlights

Cash, cash equivalents and marketable securities totaled $31.8 million as of December 31, 2017, as compared to $42.6 million as of December 31, 2016. The decrease of $10.8 million was primarily due to $36.1 million of net cash used in operating activities and a debt restructuring payment of $7.6 million, partially offset by $14.4 million in net proceeds primarily from sales of common shares through the company’s at-the-market equity facility. An additional $18.5 million in net proceeds were raised through a public offering in October 2017. This capital is expected to fund the company into 2019.

Revenues for the year ended December 31, 2017 were $0.7 million, as compared to $2.5 million for 2016. The decrease between the periods was primarily due to deferred revenue recognized related to the Royalty Agreement with Royalty Pharma.

Research and development expenses were $3.7 million and $21.5 million for the three months and year ended December 31, 2017, as compared to $4.8 million and $22.9 million for the same periods in 2016, primarily relating to the SNS-062 and the vosaroxin development program in each period. The decrease of $1.4 million in 2017 was primarily due to a decrease in professional services and $0.5 million in salary and personnel costs partially offset by the $2.5 million milestone payment to Biogen under the license agreement.

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General and administrative expenses for the three months and year ended December 31, 2017 were $2.7 million and $13.5 million, as compared to $3.9 million and $16.1 million for the same periods in 2016. The decrease of $2.6 million in 2017 was primarily due to decreases of $1.6 million in salary and personnel costs, $0.8 million in commercial expenses, and $0.3 million in office and related expenses.

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Interest expense was $0.3 million and $1.4 million for the three months and year ended December 31, 2017, as compared to $0.5 million and $1.7 million for the same periods in 2016. The decrease in the 2017 periods was primarily due to the decrease in the outstanding notes payable.

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Cash used in operating activities was $36.1 million for the year ended December 31, 2017, as compared to $37.0 million for the same period in 2016. Net cash used in operating activities in 2017 resulted primarily from the net loss of $35.5 million and changes in operating assets and liabilities of $4.0 million, offset by net adjustments for non-cash items of $3.3 million. Net cash used in operating activities in 2016 resulted primarily from the net loss of $38.0 million, offset by changes in operating assets and liabilities of $4.1 million.

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Sunesis reported loss from operations of $6.4 million and $34.4 million for the three months and year ended December 31, 2017, as compared to $8.1 million and $36.5 million for the same periods in 2016. Net loss was $6.6 million and $35.5 million for the three months and year ended December 31, 2017, as compared to $8.5 million and $38.0 million for the same periods in 2016.

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Conference Call Information

Sunesis will host a conference today at 4:30 p.m. Eastern Time. The call can be accessed by dialing (844) 296-7720 (U.S. and Canada) or (574) 990-1148 (international) and entering passcode 8182338. To access the live audio webcast, or the subsequent archived recording, visit the "Investors and Media – Calendar of Events" section of the Sunesis website at www.sunesis.com. The webcast will be recorded and available for replay on the company’s website for two weeks.

On March 8, 2018 Pfenex Inc. (NYSE American: PFNX) announced today that its fourth quarter and full year 2017 financial results will be released on Thursday, March 15, 2018, after the market close (Press release, Pfenex, MAR 8, 2018, View Source/2018-03-08-Pfenex-to-Report-Fourth-Quarter-and-Full-Year-2017-Results-and-Provide-Business-Update-on-Thursday-March-15-2018" target="_blank" title="View Source/2018-03-08-Pfenex-to-Report-Fourth-Quarter-and-Full-Year-2017-Results-and-Provide-Business-Update-on-Thursday-March-15-2018" rel="nofollow">View Source [SID1234524569]). Pfenex management will host a corresponding conference call and a live webcast at 1:30pm PT/4:30pm ET on the same day to discuss the financial results and provide a business update.

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Pfenex logo (PRNewsFoto/Pfenex)

Please call 1-866-376-8058 (US) or 1-412-542-4131 (international) and reference Pfenex to access the call. A replay of the conference call will be available approximately one hour after the call until March 22, 2018. To access the teleconference replay please call 1-877-344-7529 (US) or 1-412-317-0088 (international) and enter the passcode 10117964. The conference call will also be available as a webcast. To access the webcast link please log on to www.pfenex.com (View Source).

Pfenex investors and others should note that we announce material information to the public about the Company through a variety of means, including our website (View Source), our investor relations website (View Source), press releases, SEC filings, public conference calls, corporate Twitter account (View Source), Facebook page (View Source), and LinkedIn page (View Source) in order to achieve broad, non-exclusionary distribution of information to the public and to comply with our disclosure obligations under Regulation FD. We encourage our investors and others to monitor and review the information we make public in these locations as such information could be deemed to be material information. Please note that this list may be updated from time to time.

About Pfenex Inc.

On March 8, 2018 PDL BioPharma, Inc. (PDL or the Company) (NASDAQ: PDLI) reported financial results for the fourth quarter and year ended December 31, 2017 including (Press release, PDL BioPharma, MAR 8, 2018, View Source [SID1234524568]):

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Total revenues of $68.0 million and $320.1 million for the three and twelve months ended December 31, 2017, respectively.
GAAP diluted EPS of $0.15 and $0.71 for the three and twelve months ended December 31, 2017, respectively.
GAAP net income attributable to PDL’s shareholders of $22.3 million and $110.7 million for the three and twelve months ended December 31, 2017, respectively.
Non-GAAP net income attributable to PDL’s shareholders of $24.8 million and $100.7 million for the three and twelve months ended December 31, 2017. 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.
"2017 was a great year for us and one where we experienced a 31 percent increase in revenue from the previous year," stated John P. McLaughlin, chief executive officer of PDL. "Since 2012, we have built a rich portfolio of income generating assets and products to replace revenues from our expired Queen et al patents. We expect the revenues from these assets, whose net book value is $5.54 per share, to fuel the building of our specialty pharma business. It’s important to note that $264 million, or 83 percent of our 2017 revenues, came from sources other than the Queen et al patents. In 2018, we need to continue to execute successfully on our business model as well as close the gap between our share price and our book value per share."

Revenue Highlights

Total revenues of $68.0 million for the three months ended December 31, 2017 included:
Royalties from PDL’s licensees to the Queen et al. patents of $4.5 million, which consisted of royalties earned on sales of Tysabri;
Net royalty payments from acquired royalty rights and a change in fair value of the royalty rights assets of $30.1 million, which consisted of the change in estimated fair value of our royalty right assets, primarily related to Depomed, Inc. (Depomed) royalty asset;
Interest revenue from note receivable investment to CareView Communications of $0.8 million; and
Product revenues of $32.6 million, which consisted of $25.1 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 $7.5 million for product sales of the LENSAR Laser System.
Total revenues increased by 2 percent for the three months ended December 31, 2017, when compared to the same period in 2016.
Royalties from PDL’s licensees to the Queen et al. patents were lower due to reduced sales of Tysabri that was manufactured prior to the patent expiry date;
PDL received $32.8 million in net cash royalties from its royalty rights in the fourth quarter of 2017, compared to $25.3 million for the same period of 2016. The increase in cash royalties is mainly due to a one-time settlement payment from Valeant related to the royalty audit of Glumetza and the launch of the authorized generic for Glumetza sold by Valeant Pharmaceuticals International, Inc. PDL received royalties on the authorized generic equivalents under the same terms as the branded Glumetza;
The decrease in interest revenues was primarily due to the sale of the kaléo, Inc. note receivable in September 2017; and
The increase in product revenues were derived from the sale of the LENSAR Laser System, which PDL did not begin to recognize until May 2017.
Total revenues increased by 31 percent for the year ended December 31, 2017, when compared to the year ended December 31, 2016.
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. and reduced royalties on Tysabri.
The increase in royalty rights – change in fair value was primarily due to the year-to-date increase in fair value of the Depomed royalty asset by $134.1 million.
PDL received $107.3 million in net cash royalties, including a one-time settlement payment from Valeant related to the royalty audit of Glumetza, from its royalty rights in the year ended December 31, 2017, compared to $72.6 million for the same period of 2016.
The decrease in interest revenues was primarily due to the early repayment of the Paradigm Spine, LLC note receivable and the sale of the kaléo, Inc. note receivable.
Product revenue increased due to sales of the Noden Products, which PDL did not begin to recognize until the third quarter of 2016, and sales of the LENSAR Laser System, which PDL did not begin to recognize until May 2017.
License and other revenue increased by $19.6 million primarily due to a one-time $19.5 million payment from Merck as part of the previously announced settlement agreement to resolve the patent infringement lawsuit related to Keytruda.
Operating Expense Highlights

Operating expenses were $38.2 million for the three months ended December 31, 2017, compared to $74.2 million for the same period of 2016. The decrease in operating expenses for the three months ended December 31, 2017, as compared to the same period in 2016, was primarily a result of the prior year period loss on extinguishment of Direct Flow Medical notes receivable, partially offset by the increase in operating expenses related to the acquisitions and operations of Noden and LENSAR, contributing an additional $13.8 million of cost of product revenue and $6.0 million in sales and marketing expenses due to an increase in Noden’s sales force.
Operating expenses were $126.3 million for the year ended December 31, 2017, compared to $114.9 million for the year ended December 31, 2016. The increase in operating expenses in 2017 was a result of the acquisitions and operations of Noden and LENSAR, contributing an additional $26.5 million of cost of product revenue, $12.7 million of intangible asset amortizations, $17.1 million in sales and marketing expenses, and $3.6 million in research and development costs for the completion of a pediatric trial for Tekturna. General administrative expenses increased by $5.9 million of which $7.5 million was related to Noden and $3.2 million was related to LENSAR, partially offset by a decrease of $51.1 million from the loss on extinguishment for the Direct Flow Medical notes receivable in 2016.
Recent Developments

On February 1, 2018, PDL completed the retirement of the remaining $126.4 million of aggregate principal of its 4.0% Convertible Senior Notes due 2018 at their stated maturity by making a payment to the noteholders of $126.4 million, plus $2.6 million of accrued interest.
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.
Other Financial Highlights

PDL had cash, cash equivalents, short-term investments and other investments of $532.1 million at December 31, 2017, compared to $242.1 million at December 31, 2016.
Conference Call and Webcast Details

PDL will hold a conference call to discuss financial results at 4:30 p.m. Eastern Time today, March 8, 2018.

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 9384627. 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 one week following the call, and may be accessed by dialing (855) 859-2056 from the United States and Canada or (404) 537-3406 internationally. The replay passcode is 9384627.

To access the live and subsequently archived webcast of the conference call, go to the Company’s website at View Source and go to the Investor Relations section and select "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.