On March 9, 2017 Merck, a leading science and technology company, reported finishing 2016 with record figures and continues to grow profitably (Press release, Merck KGaA, MAR 9, 2017, View Source [SID1234518059]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Sales and earnings rose significantly. Major strategic advances were made in all three business sectors.

"2016 was a successful year for Merck. In Healthcare, two of our compounds are in registration. In our Life Science business sector, we made rapid progress with the integration of Sigma-Aldrich. We have moved ahead faster and even better than expected with the realization of synergies. At the same time, the business generated notable organic growth. With its four strong businesses, Performance Materials showed robustness in a challenging market environment. We maintained our strategically important market leadership in display materials and purposefully drove new technologies forward," said Stefan Oschmann, Chairman of the Executive Board and CEO of Merck.
Net sales of the Merck Group increased sharply by 17.0% to € 15.0 billion in 2016 (2015: € 12.8 billion). All regions contributed to organic sales growth of 3.2%. The purchase of Sigma-Aldrich was responsible for an acquisition-related sales increase of 16.4%. By contrast, negative exchange rate effects, which were mainly attributable to Latin American currencies, lowered Group sales by -2.6%.

The operating result (EBIT) rose by 34.6% to € 2.5 billion (2015: € 1.8 billion). EBITDA pre exceptionals, the company’s key earnings indicator, climbed 23.7% to € 4.5 billion. Thanks to the Healthcare and Life Science business sectors, this figure was considerably higher than in the previous year (2015: € 3.6 billion).

Net income rose by 46.1% to € 1.6 billion in 2016 (2015: € 1.1 billion). This positive development was also due to the gain from the return of the rights to Kuvan to BioMarin Pharmaceutical at the beginning of 2016.

Earnings per share pre exceptionals rose by 27.5% to € 6.21 (2015: € 4.87). The proposal to the Annual General Meeting on April 28, 2017 will be to increase the dividend by € 0.15 to € 1.20 per share. Merck will have thus increased its dividend every year since 2009.

The figures for sales, EBITDA pre exceptionals and earnings per share pre exceptionals were within the upgraded target corridor that Merck had most recently announced in its report on the third quarter in November 2016.

Net financial debt, which mainly stems from the Sigma-Aldrich acquisition, decreased to € 11.5 billion at the end of 2016 (December 31, 2015: € 12.7 billion). Merck will resolutely continue along this path. As of December 31, 2016, Merck had 50,414 employees worldwide (December 31, 2015: 49,613).

Healthcare and Life Science drive Group organic sales growth in the fourth quarter
In the fourth quarter of 2016, Group sales rose by 10.6% to € 3.8 billion (Q4 2015: € 3.5 billion). This was driven not only by organic growth attributable to Healthcare and Life Science, but also by strong acquisition-related sales growth from the purchase of Sigma-Aldrich. EBITDA pre exceptionals grew by 15.1% to € 1.1 billion in the fourth quarter of 2016 (Q4 2015: € 933 million). Earnings per share pre exceptionalsincreased significantly by 26.5% in the fourth quarter of 2016 to € 1.43 (Q4 2015: € 1.13).

Healthcare grows organically and makes progress with registrations
Net sales of the Healthcare business sector rose organically by 4.6% in 2016. Organic growth was canceled out by negative exchange rate effects of –4.6%, as well as a negative portfolio effect of -1.1% from the sale of the rights to Kuvan. Consequently, Healthcare sales declined in 2016 by –1.1%, amounting to € 6.9 billion (2015: € 6.9 billion).

Sales of Rebif, which is used to treat relapsing forms of multiple sclerosis, declined organically by only –1.7% in 2016 despite continued competitive pressure from oral formulations. Amid currency headwinds of -1.5%, Rebif sales amounted to € 1.7 billion (2015: € 1.8 billion). In 2016, sales of the oncology drug Erbitux totaled € 880 million (2015: € 899 million). Organic growth of 1.1% was canceled out by negative foreign exchange effects of -3.2%. With Gonal-f, the leading recombinant hormone used in the treatment of infertility, in 2016 Merck generated strong organic sales growth of 12.4%, also benefiting from the competitive environment in the United States. Including negative foreign exchange effects of -2.5%, sales rose to € 753 million (2015: € 685 million).

Despite higher research and development expenses mainly in connection with clinical development projects in immuno-oncology, EBITDA pre exceptionals of Healthcare grew by 6.3% to € 2.1 billion (2015: € 2.0 billion).

Currently, both the multiple sclerosis treatment cladribine tablets and the oncology drug avelumab are in registration.

Life Science delivers strong organic growth despite Sigma-Aldrich integration
In 2016, net sales of the Life Science business sector soared by 68.6% to € 5.7 billion (2015: € 3.4 billion) and profitability rose. At 6.3%, Life Science again delivered strong organic growth, outpacing the market. The acquisition-related increase of 63.1% from the purchase of Sigma-Aldrich had a very strong impact on sales amid slightly negative exchange rate effects of -0.8%. Life Science made good progress with the integration of Sigma-Aldrich, including the realization of synergies. At the end of 2016, annually recurring cost synergies of € 105 million had already been leveraged as compared with the originally planned amount of € 90 million for this period. In addition, thanks to previously unplanned top-line synergies, by the end of 2018 total synergies from the acquisition will amount to € 280 million instead of the originally planned € 260 million per year, as previously announced at Capital Market Day in October 2016.

The Process Solutions business area, which markets products and services for the entire pharmaceutical production value chain, generated organic sales growth of 10.5%. The Research Solutions business area, which focuses on academia and pharmaceutical research institutions, delivered organic sales growth of 1.2%. Sales by Applied Solutions, which serves clinical and diagnostic testing laboratories as well as the food and environmental industries, grew organically by 4.3%.

EBITDA pre exceptionals of Life Science rose in 2016 by 93.0% to € 1.7 billion (2015: € 856 million), reflecting the strong development of the combined Life Science business.

Performance Materials remains robust in a difficult market environment
Net sales by the Performance Materials business sector declined in 2016 by -1.8% to € 2.5 billion (2015: € 2.6 billion). This was mainly due to the -4.7% organic decrease in sales. Acquisition-related growth of 2.7% from the SAFC Hitech business of Sigma-Aldrich acquired in 2015 and exchange rate effects of 0.2% could only partly offset this.

The Display Materials business unit, which comprises the business with liquid crystals and complementary materials, saw a sharp organic decline in sales in 2016 yet still maintained its market leadership position. The decline in sales resulted from a strong previous year as well as destocking by display industry customers. One exception was the energy-saving UB-FFS technology used in the latest generation of smartphones. Here, double-digit growth was achieved along with record sales in the fourth quarter. The Integrated Circuit Materials business unit also showed strong organic sales growth. The Pigments & Functional Materials business unit delivered solid organic sales growth in 2016. Growth in the Advanced Technologies business unit was driven by double-digit sales increases for OLED materials; a new OLED production unit was opened in Darmstadt in September 2016.

EBITDA pre exceptionals of Performance Materials fell by -2.3% to € 1.1 billion (2015: €  1.1 billion).

Sales growth and stable EBITDA pre exceptionals forecast for 2017
For the Group, Merck expects slight to moderate organic sales growth in 2017 in comparison with the previous year. EBITDA pre exceptionals of the Merck Group should remain about stable compared with 2016; this encompasses a slightly positive or negative percentage fluctuation around the previous year’s level.
Merck Group – Key figures
€ million
2016
2015
Change
in %
Q4 2016
Q4 2015
Change
in %
Net sales
15,024
12,845
17.0
3,830
3,464
10.6
Operating result (EBIT)
2,481
1,843
34.6
405
298
36.0
Margin (% of net sales)
16.5
14.3
10.6
8.6
EBITDA
4,415
3,354
31.6
953
803
18.7
Margin (% of net sales)
29.4
26.1
24.9
23.2
EBITDA pre exceptionals
4,490
3,630
23.7
1,075
933
15.1
Margin (% of net sales)
29.9
28.3
28.1
26.9
Earnings per share (€)
3.75
2.56
46.5
0.62
0.29
113.8
Earnings per share pre exceptionals (€)
6.21
4.87
27.5
1.43
1.13
26.5
Net income
1,629
1,115
46.1
269
126
113.8
Dec. 31, 2016
Dec. 31, 2015
Net financial debt
11,513
12,654
– 9.0

On March 9, 2017 MorphoSys AG (FSE: MOR; Prime Standard Segment, TecDAX; OTC: MPSYY), a leader in the field of therapeutic antibodies, reported results for the financial year 2016, as well as a financial and operational outlook on 2017 (Press release, MorphoSys, MAR 8, 2017, View Source [SID1234518045]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"2016 was a rewarding year for us. The first therapeutic antibody from our platform was filed for market approval by our pharma partner Janssen, which is a major milestone in our company’s history. We expect the decision on regulatory filing of guselkumab in the second half of 2017," said Dr. Simon Moroney, Chief Executive Officer of MorphoSys AG. "In parallel, we made significant progress with our own drug candidates in 2016. Across our pipeline we see many programs which have the potential to transform the treatment of the diseases they address and thus to create value and benefit for all our stakeholders, including our partners, investors and patients."

"With a record-high of 114 programs in R&D, MorphoSys’s portfolio is one of the broadest in the biopharmaceutical industry. This pipeline is supported by financial resources of close to EUR 360 million at year-end 2016. We strengthened our financial position by a successful capital increase with gross proceeds of EUR 115.4 million in November 2016. Our financial strength enables us to invest strongly in the development of our own drug candidates to grow the Company’s value, without losing sight of our prudent and efficient use of resources," commented Jens Holstein, Chief Financial Officer of MorphoSys AG.

Financial Review for the Fiscal Year 2016 (IFRS)

In 2016 MorphoSys continued to focus on the research and development of drug candidates both for partners and on its own account. Group revenues came in at EUR 49.7 million, fully in line with expectations (2015: EUR 106.2 million). Adjusted for a 2015 one-off income of approximately EUR 59 million, 2016 revenues rose by 5% compared to the previous year.

In the Proprietary Development segment, MorphoSys focuses on the research and clinical development of its own drug candidates in the fields of cancer and inflammation. In 2016, this segment recorded revenues of EUR 0.6 million, an almost flat revenue development compared to 2015, as previous year’s numbers (2015: EUR 59.9 million) included a one-off effect of approximately EUR 59 million from the termination of the MOR202 co-development and co-promotion agreement with Celgene.

In the Partnered Discovery segment, MorphoSys applies its proprietary technology to discover new antibodies for pharmaceutical companies, benefitting from the partners’ development advancements through success-based milestone payments and royalties. In 2016, revenues were up 6% to EUR 49.1 million (2015: EUR 46.3 million). The increase was mainly driven by milestone payments from partners. Segment revenues in 2016 comprised EUR 43.6 million in funded research and license fees (2015: EUR 42.3 million) and EUR 5.6 million in success-based payments (2015: EUR 4.0 million).

Total operating expenses came in at EUR 109.8 million, exceeding last year’s numbers by 17% (2015: EUR 93.7 million). While general and administrative expenses were reduced by 7% to EUR 14.1 million (2015: EUR 15.1 million), research and development expenses were increased by 22% to EUR 95.7 million (2015: EUR 78.7 million). Intensified clinical trials with MorphoSys’s proprietary drug candidates, in particular the start of three phase 2 studies with the lead compound MOR208 in selected blood cancer indications, were the main area of focus. Proprietary R&D expenses, including technology development, rose by 39% to EUR 78.5 million (2015: EUR 56.6 million), fully meeting the Company’s guidance.

Earnings before interest and taxes (EBIT) stood at EUR -59.9 million (2015: EUR 17.2 million). Adjusted for the one-off effect in 2015, the operating loss for 2016 rose by approximately 43%, mainly based on the planned expansion of R&D activities. The Proprietary Development segment reported an EBIT of EUR -77.6 million (2015: EUR 10.7 million). EBIT in the Partnered Discovery segment was up by 52% to EUR 31.0 million (2015: EUR 20.4 million), mainly based on the increase in success-based milestone payments from partners and lower costs incurred in the segment.

In 2016, the consolidated net result amounted to EUR -60.4 million (2015: EUR 14.9 million). The diluted net result per share for 2016 was EUR -2.27 (2015: EUR 0.57).

At year-end 2016, the Company had a cash position of EUR 359.5 million compared to EUR 298.4 million on December 31, 2015. On the balance sheet, this cash position is reported under the items: cash and cash equivalents; available-for-sale financial assets; bonds, available-for-sale; financial assets classified as loans & receivables; and financial assets classified as loans & receivables, net of current portion.

The number of shares issued totaled 29,159,770 at year-end 2016 (year-end 2015: 26,537,682). The increase in the number of shares resulted from the capital increase on November 15, 2016 with gross proceeds of EUR 115.4 million, in which 2,622,088 shares were issued.

Financial Guidance and operational outlook for 2017

For the financial year 2017, MorphoSys expects to generate Group revenues in the range of EUR 46 to 51 million. R&D expenses for proprietary drug development are anticipated in a corridor of EUR 85 to 95 million. The Company expects earnings before interest and taxes (EBIT) of EUR -75 to -85 million. This guidance does not include any additional revenue from potential future collaborations and/or licensing partnerships nor effects from potential in-licensing or co-development deals for new development candidates.

"We continue to invest in our growing portfolio of highly promising proprietary drug candidates which are nearing the decisive stages of clinical development. In 2017 we will start a phase 3 study with our lead candidate MOR208 in the blood cancer indication diffuse large B cell lymphoma (DLBCL), where we see a high unmet medical need. This will be the first pivotal trial with one of our own antibodies. This marks another important step on our way to becoming a fully-integrated biopharmaceutical company, that will be increasingly based on product-based revenue streams," commented Dr. Simon Moroney.

In the Proprietary Development segment, MorphoSys expects the following events in 2017:

MOR208: Completion of the phase 2 safety run-in of the B-MIND study and initiation of the pivotal phase 3 part of the study, in which MOR208 will be tested in combination with bendamustine in comparison to rituximab and bendamustine in DLBCL.
MOR208: Presentation of first preliminary data of the phase 2 trial of MOR208 in combination with lenalidomide in DLBCL (L-MIND study).
MOR208: Initiation of another study arm of the ongoing phase 2 COSMOS trial with MOR208 in CLL in order to test MOR208 with a further combination drug. Currently, the Company is investigating the combination of MOR208 and idelalisib in this study.
MOR202: Completion of the phase 1/2a dose-escalation trial in multiple myeloma, including the results of MOR202 in the highest dose of 16 mg/kg alone and in combinations with pomalidomide and with lenalidomide.
MOR209/ES414: Continuation of the phase 1 trial of MOR209/ES414 with adapted dose regimen in prostate cancer (mCRPC) as part of the collaboration with Aptevo.
MOR106: Completion of the phase 1 trial of MOR106, co-developed with Galapagos, in atopic dermatitis.
MOR107: Completion of a phase 1 study in healthy volunteers.
MOR103/GSK3196165: For this HuCAL antibody, which has been fully out-licensed to GSK, MorphoSys expects data from a phase 2b study in rheumatoid arthritis and from a phase 2a study in hand osteoarthritis, both conducted by GSK.
In its Partnered Discovery segment, MorphoSys expects the following events in 2017:

Guselkumab: the first partner-developed therapeutic antibody based on MorphoSys’s HuCAL technology could receive market approval in 2017. MorphoSys expects that the US regulatory authority FDA should make a decision in the second half of 2017 on Janssen’s application for the approval of guselkumab to treat adults with moderate to severe psoriasis. In addition, a regulatory filing for guselkumab in Europe has been submitted.
Anetumab ravtansine, a HuCAL antibody drug conjugate developed by Bayer, is expected to report results in 2017 from a pivotal phase 2 trial in the cancer indication mesothelioma. Favourable results could support a regulatory filing of the compound.
Novartis collaboration: As previously communicated and as reflected in the Company’s 2017 guidance, MorphoSys expects the collaboration with Novartis to end at the end of November 2017 in accordance with the contract. The Company does not believe that Novartis will exercise its option to extend the contract.
In total, results may be disclosed from up to 31 different clinical studies in various phases conducted by partners with antibodies based on MorphoSys technology.
MorphoSys plans to establish additional collaborations with pharmaceutical and biotechnology companies based on the Ylanthia technology, similar to its partnership with LEO Pharma established in 2016.

MorphoSys Group Key Figures (IFRS, end of financial year: December 31)

in EUR million 2016 2015 Change Q4/2016 Q4/2015 Change
Revenues 49.7 106.2* -53% 13.0 12.3 +6%
Operating expenses 109.8 93.7 +17% 40.7 30.1 +35%
R&D expenses 95.7 78.7 +22% 36.9 25.6 +44%
Proprietary R&D expenses 78.5 56.6 +39% 32.3 16.7 +93%
G&A expenses 14.1 15.1 -7% 3.8 4.5 -16%
EBIT -59.9 17.2* >-100% -27.6 -17.5 +58%
Net result -60.4 14.9 >-100% -28.7 -13.3 >100%
Net result per share (diluted) (in EUR) -2.27 0.57 >-100% -1.04 -0.58 +79%
Cash position (end of period) 359.5 298.4 +20% 359.5 298.4 +20%
Equity ratio (end of period) (in %) 90% 91% -1 PP** 90% 91% -1 PP**
No of R&D programs (end of period) 114 103 +11 114 103 +11
No of clinical programs (end of period) 29 25 +4 29 25 +4
No of proprietary clinical programs (end of period) 5 4 +1 5 4 +1
* Adjusted by a positive one-off effect of approximately EUR 59 million in revenue and EBIT of 2015, total Group revenues reached approximately EUR 47 million and the total Group EBIT approximately EUR -42 million in 2015.
** Percentage point

MorphoSys will hold its conference call and webcast today to present the annual financial results 2016 and the outlook 2017.

On March 8, 2017 Celyad (Euronext Brussels and Paris, and NASDAQ: CYAD), a leader in the discovery and development of engineered cell-based therapies, reported that the U.S. FDA authorized the initiation of the THINK trial in the U.S (Filing, 6-K, Celyad, MAR 8, 2017, View Source [SID1234518038]). THINK evaluates NKR-2 CAR-T cells in seven indications, five solid cancers and two hematological malignancies.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"The FDA approval for the THINK trial is an important milestone allowing us to initiate the THINK clinical trial in the USA. We are now looking forward to enrolling the first patients in both solid and hematological arms of the study in the U.S.", said Christian Homsy, CEO of Celyad.

"I would like to thank the team as well as our partners for the incredible work achieved so far to make the THINK trial progress at such a good pace. In the coming months, all our efforts will be dedicated to the recruitment and follow-up of new patients for each dose-level cohort, but also to the opening of new clinical sites across EU and the U.S.", remarked Jean-Pierre Latere, Chief Operating Officer at Celyad.

On March 8, 2016 Spectrum Pharmaceuticals, Inc. (NasdaqGS: SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in Hematology and Oncology, reported financial results for the three-month period and year ended December 31, 2016 (Press release, Spectrum Pharmaceuticals, MAR 8, 2017, View Source [SID1234518035]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We made significant advancements in our pipeline throughout 2016 and I believe we are well positioned for transformational growth," said Rajesh C. Shrotriya, MD, Chairman and Chief Executive Officer of Spectrum Pharmaceuticals. "ROLONTIS is our highest priority drug and we are pleased that we remain on track for a BLA filing next year. Poziotinib, which is being developed for breast cancer has recently emerged as a potential treatment for a high unmet medical need in lung cancer. Data presented in December suggests that poziotinib has potential in lung cancer patients with certain genetic mutations that have poor prognosis and limited treatment options. An investigator sponsored trial of poziotinib in such patients with EGFR Exon 20 insertion mutations at MD Anderson Cancer Center could yield key results before year end. We have also obtained a new SPA for our late-stage bladder cancer drug Qapzola that significantly reduces the number of patients required for an NDA filing. Spectrum is in a unique position of having multiple opportunities to create value while benefiting patients."

Pipeline Update:

ROLONTIS (eflapegrastim), a novel long-acting GCSF: A pivotal Phase 3 study was initiated under a SPA from the FDA in 2016 to evaluate ROLONTIS in the management of chemotherapy-induced neutropenia in patients with breast cancer. The Company is actively enrolling breast cancer patients in the current trial, expects to initiate an additional smaller Phase 3 trial, and continues to expect to file a BLA next year.
Poziotinib, a potential best-in-class, novel, pan-HER inhibitor: In collaboration with The University of Texas MD Anderson Cancer Center, an investigator sponsored trial is being initiated in non-small cell lung cancer patients with EGFR Exon 20 insertion mutations. The study is expected to yield results before year end. Spectrum is also conducting a Phase 2 breast cancer trial in the U.S., based on promising Phase 1 efficacy data in breast cancer patients who had failed multiple other HER2-directed therapies. Further, multiple Phase 2 studies are being conducted in South Korea by Hanmi Pharmaceuticals and National OncoVenture to study additional cancer indications.
Qapzola, a potent tumor-activated drug being investigated for non-muscle invasive bladder cancer: The Company received a new SPA from the FDA on a proposed Phase 3 study design. The Phase 3 study has been specifically designed to build on learnings from the previous studies, as well as recommendations from the FDA. Compared to the previous study, this study will use twice the dosage of Qapzola (8 mg), will evaluate approximately 70% fewer patients (n = 425), and will evaluate time-to-recurrence as the primary endpoint compared to recurrence at 2 years.
Three-Month Period Ended December 31, 2016 (All numbers are approximate)

GAAP Results

Total product sales were $32.2 million in the fourth quarter of 2016. Product sales in the fourth quarter included: FUSILEV (levoleucovorin) net sales of $4.3 million, FOLOTYN (pralatrexate injection) net sales of $10.7 million, ZEVALIN (ibritumomab tiuxetan) net sales of $2.5 million, MARQIBO (vinCRIStine sulfate LIPOSOME injection) net sales of $2.3 million, BELEODAQ (belinostat for injection) net sales of $3.0 million, and EVOMELA (melphalan) for injection net sales of $9.4 million.

Spectrum recorded net loss of $17.4 million, or $0.22 per basic and diluted share in the three-month period ended December 31, 2016, compared to net loss of $4.2 million, or $0.06 per basic and diluted share in the comparable period in 2015. Total research and development expenses were $15.9 million in the quarter, as compared to $15.4 million in the same period in 2015. Selling, general and administrative expenses were $18.3 million in the quarter, compared to $21.2 million in the same period in 2015.

During the quarter the Company purchased $10.0 million face value of its convertible debentures for $9.0 million. The Company ended the quarter with cash and cash equivalents of $158 million.

Non-GAAP Results

Spectrum recorded non-GAAP net loss of $8.1 million, or $0.10 per basic and diluted share in the three-month period ended December 31, 2016, compared to non-GAAP net loss of $4.6 million, or $0.07 per basic and diluted share in the comparable period in 2015. Non-GAAP research and development expenses were $15.4 million, as compared to $14.8 million in the same period of 2015. Non-GAAP selling, general and administrative expenses were $15.6 million, as compared to $18.1 million in the same period in 2015.

Twelve-Month Period Ended December 31, 2016 (All numbers are approximate)

GAAP Results

Total product sales were $128.6 million for the twelve months ended December 31, 2016. Total product sales decreased 6% from $136.9 million in the same period of 2015.

Product sales in 2016 included: FUSILEV (levoleucovorin) net sales of $34.8 million, FOLOTYN (pralatrexate injection) net sales of $46.2 million, ZEVALIN (ibritumomab tiuxetan) net sales of $10.7 million, MARQIBO (vinCRIStine sulfate LIPOSOME injection) net sales of $7.2 million, BELEODAQ (belinostat) for injection net sales of $13.4 million, and EVOMELA (melphalan) for injection net sales of $16.2 million.

Spectrum recorded net loss of $68.5 million, or $0.94 per basic and diluted share in the twelve-month period ended December 31, 2016, compared to net loss of $50.8 million, or $0.78 per basic and diluted share in the comparable period in 2015. Total research and development expenses were $58.9 million for the year, as compared to $50.8 million in the same period in 2015. Selling, general and administrative expenses were $87.3 million for the year, compared to $86.5 million in the same period in 2015.

Non-GAAP Results

Spectrum recorded non-GAAP net loss of $16.8 million, or $0.23 per basic and diluted share in the twelve-month period ended December 31, 2016, compared to non-GAAP net loss of $17.6 million, or $0.27 per basic and diluted share in the comparable period in 2015. Non-GAAP research and development expenses were $54.1 million, as compared to $45.7 million in the same period of 2015. Non-GAAP selling, general and administrative expenses were $64.1 million, as compared to $77.9 million in the same period in 2015.