Fr. Emmanuel Lemelson Letter To Congress Regarding Ligand
Fr. Emmanuel Lemelson Letter To Congress Regarding Ligand
Emmanuel Lemelson
The Lantern Foundation
225 Cedar Hill Street Suite # 200
Marlborough, MA 01752
December 21, 2016
Public policy must be constructed and enforced in ways that account not only for the companies driving
these unethical and likely illegal entities, but also their enablers, who work for a cut of the profits. In
addition to investigating these abuses by Ligand, Congress must act swiftly to tighten the Orphan Drug
Act to ensure drugs meet the legitimate purpose intended under this statute to prevent these abuses, and
ensure policy reforms to fast-track the approval of generics are passed.
Separately, this past January, after several years of research into Ligand, a whistleblower report was filed
with the U.S. Securities and Exchange Commission (SEC) regarding Ligands material misrepresentations
to investors.
I am attaching a more detailed report on Ligand's extensive abuses of pharmaceutical classification,
pricing, accounting and other regulations, standards and statutes.
I strongly encourage the Committee to commence an investigation into Ligand. I also will gladly make
myself available to the Committee to review and understand these abuses and to testify under
Congressional oath on them.
Thank you for your attention to this important matter.
Sincerely,
Enclosure
cc:
U.S. Senate Special Committee on Aging members
Kevin L. Kelley, Staff Director
Derron Reynard Parks, Staff Director
Mia Lenee Woodward, Investigative Counsel
Background
Ligand Pharmaceuticals so-called licensing model is a nexus for a new breed of unethical
pharmaceutical companies whose primary goal is to reap extraordinary profits on the backs of patients,
taxpayers and shareholders by (among other things) abusing the Orphan Drug Act of 1983 as well as a
litany of accounting standards. In fact, it is Ligand that systemized the monopoly pricing practices that
has given rise to similar accounting and regulatory abuses subsequently adopted by Valeant, Martin
Shkrelis Retrophin, Mylan and other pharmaceutical companies, which the Committee previously has
called as witnesses.
The Ligand business model is not based on finding the best drugs to cure or treat rare conditions, as the
Orphan Drug Act, which Ligand is exploiting, encourages. Instead, Ligands model consists of locating
drugs whose price, through the Orphan Drug Act, can be continually and radically increased with negligible
benefit to patients with these rare conditions.
(3) Ligand seeks and obtains orphan drug designation for these drugs, which then bars generic
competition and enables virtually unlimited price increases because of the veritable
monopoly the designation creates for these drugs; and
(4) Ligand then licenses these monopolistic drugs to companies that raise the price on these lowprofile medications, which are now protected from competition due to their orphan drug
status.
What sets Ligand apart from Retrophin, Turing, Valeant, Mylan and others is that, unlike these companies
which have exploited the opportunity for nearly limitless price increases on some of their drugs, this is
Ligands exclusive mission and function. In fact, no company is currently more engaged than Ligand in
abusing the Orphan Drug Act for the purpose of grossly increasing drug prices that are ultimately absorbed
by taxpayers.
As is the case with both of Ligands primary royalty-generating drugs, both of which have been granted
orphan drug status, Ligand is generating massive royalties from drugs for which vastly cheaper and
typically equally and if not more effective alternatives exist.
The first disgraceful example is Ligands licensing of Kyprolis1, a failed oncology drug that has shown no
progression-free survival benefit over its much less expensive competitors.2 Despite Kyprolis lack of
clinical efficacy, however, the federal Medicare program was billed roughly $280,000 per round of
treatment per patient for Kyprolis for a total of $228 million in 2015 alone, an increase of 43 percent over
2014, and $387 million over 2014 and 2015. Outrageously and unjustifiably, this now makes Kyprolis one
of the most expense drugs billed to the Centers for Medicare and Medicaid Services (CMS). 3 4
A second outrageous example can be found in Ligands other primary revenue-generating drug Promacta5.
Ligand represents that Promacta is primarily used to treat idiopathic thrombocytopenic purpura (ITP), an
extremely rare condition. In these cases, Promacta is sold to these patients at the exorbitant price of
$10,196 for 30 75 mg. tablets. Promacta is not a cure for ITP and it will not make a patients platelet counts
normal if the patient has this condition6.
Kyprolis is a drug that uses Captisol (a Ligand product) in its formulation. Ligand has a license agreement with
Amgen and receives royalties on Kyprolis sales.
2
Lemelson Capital reported in August 2014 that Kyprolis was facing extraordinary competitive threats from two
entrenched multiple myloma (MM) indications, Celgenes Revlimid and Takeda Pharmaceuticals Velcade. The
Lemelson Capital report was subsequently proven correct when Amgen Executive Vice President of Research and
Development Sean Harper noted recently that a late-stage Kyrprolis study did not meet its goal in improving
progression-free survival versus Velcade in patients who had not yet been treated for the disease.
See Update: Lemelson Capital Further Increases Short Stake in Ligand Pharmaceuticals (NASDAQ: LGND) as LGND
EPS Plunges 76 percent in Q2 2014, available here: Link
3
See: Rough Month: A Closer Look at Ligand's Fall From All-Time Highs, available here: Link
See: How Much Will Amgen's Carfilzomib for Multiple Myeloma Cost? available here: Link
5
Promacta is an oral thrombopoietin receptor agonist
6
See: What is Promacta? Drugs.com, (available here: Link).
4
Lemelson Capital Management, LLC published five research reports between June and August of 2014 outlining
materially misleading statements made by Ligand Pharmaceuticals.
8
Since 2011, Ligand has amended their quarterly and annual reports an extraordinary 14 times
In addition to these substantial abuses and misrepresentations, a significant part of the proceeds from
Ligands misclassified 2014 debt offering was used to acquire one of Ligands largest investors (BVF
Partners) stake in Ligand in a private transaction at extraordinary and misrepresented expense to Ligand
shareholders.
Finally, Grant Thornton, Ligands auditor, has also been complicit in these abuses, wrongly providing a
clean audit opinion to Ligands material misrepresentations.
Ligands documentable record of accounting, regulatory and ethical abuses is one of the worst in the
history of modern public markets. Further, the companys management team and board of directors are
operating consistently in ways that represent exclusively their own self-interests and not, as is required
of fiduciaries, those of the companys shareholders.
Variable interest entity abuses and conflicts of interest
Ligand also has significantly abused other accounting standards, including the variable interest entity (VIE)
standard. Ligands abuse of the VIE has been designed to disguise the companys true operating expenses
and create phantom profits in ways very much like Enron criminally misused special purpose entities
(SPEs).
On May 4, 2015, Viking Therapeutics, a pharmaceutical startup closely intertwined with Ligand and initially
a tenant in its La Jolla, California office building, began trading publicly on the NASDAQ stock exchange.
Ligand is mentioned 348 times in Vikings 2015 10-K9 . At the time of this IPO, Viking was operating
effectively as a Ligand proxy with Ligand sponsorship. As part of the offering, Viking sold three million
shares of its common stock at a public offering price of $8.00 per share. In connection with the IPO, Ligand
received 3.4 million Viking shares in part for agreeing to purchase $9 million worth of Vikings stock, or 38
percent of the total offering, creating both a market for the shares and a trading price that were both
engineered in advance.
Shortly after the IPO, Ligand then deconsolidated its equity stake in Viking off their balance sheet, claiming
the company was no longer a VIE. Ligand recorded a $28.2 million gain on the deconsolidation for the
year ended December 31, 2015 related primarily to the equity milestone received from Viking upon the
close of the IPO. However, Ligand retained the intellectual property in the Viking transaction and virtually
controlled Vikings stock and board10 while Viking booked the significant losses related to developing the
Ligand assets it licensed to Viking.
In 2015, Viking went on to lose approximately $23.4 million, or $3.68 per share, developing assets owned
by Ligand.
Despite the IPO support from the Ligand purchases, Viking shares recently traded as low as $0.94 per
share, a decline in value of 88.25 percent from its offering price, while Ligands 49.4 percent initial stake
in Viking common stock virtually eliminated the ability of other shareholders to influence corporate
9
matters at the company, contradicting Ligands claim that Viking was no longer a VIE at the time of its
deconsolidation off their balance sheet. Barely a year and a half later, Viking now faces almost certain
delisting from the NASDAQ stock exchange.
As of October 31, 2016, Viking had a market capitalization of approximately $21 million (roughly 23
percent less than the value of the approximately $28 million initial entry on Ligands statement of income),
which was to represent only 49.4 percent of the companys outstanding shares.
The unethically cozy relationship between Ligand and Vikings IPO underwriter Roth Capital also has
developed into a glaring conflict of interest with Roth Capital receiving transactional banking fees for
Ligands proxy Viking while absurdly placing strong buy ratings on Ligand stock and predicting even
higher future trading prices for it. In so doing, Roth Capital fails to disclose clearly its conflict of interest
to existing and prospective investors, driving Ligand stock higher and enabling stock awards and
subsequent sales by Ligand insiders.
Ligand has used Viking and other equity partners, such as Shkrelis Retrophin and TG Therapeutics, to
create a pyramid-type equity scheme used to indirectly harvest capital from public markets. This, in turn,
has been fed upstream to the effective sponsor, Ligand, which has used the entries to artificially buttress
their statement of income while their legitimate expenses have been disavowed and attributed to
surrogates further down the pyramid. Absent any scrutiny of this unethical practice by regulators or
lawmakers, Ligand now appears ready to conduct a similar transaction with Seelos Therapeutics, a
company whose website consists of just one page with an indiscernible logo and 18 characters of text
(their name) and their address11. Yet, Ligand is already representing to investors that it stands to make
millions from the licensing arrangement with Seelos and undoubtedly a future IPO.
Material misrepresentations lead to vast overvaluation
Based on Ligands multiple misrepresentations and omissions, even though the companys total revenue
increased a very modest $7 million between 2014 and 2015, its market capitalization more than doubled
(by 104 percent) from roughly $1.04 billion at FYE 2014 to approximately $2.16 billion at FYE 2015, and
recently has exploded further to nearly $3 billion. Further, in the first nine months of 2016, Ligands
income from continuing operations was just $759,000 against a market capitalization at September 30 of
$2.1 billion, or an extraordinary 2,800 times trailing nine-month income from continuing operations.
Ligands real income (excluding non-cash items) is down 80.8 percent12 year over year through year-end
2015, cash and cash equivalents have dropped by roughly 40 percent year over year13, and the companys
long-term debt has increased from $196 million to $205 million in the same timeframe.
11
Meanwhile, Ligand has taken equity in three companies (not including its recent transaction announced
with Seelos Therapeutics) with combined deficits of $268.9 million and combined losses in 2015 of $137.1
million while representing its stake in these companies as $30.4 million in income on its statement of
operations, an accounting abuse that is entirely misleading.
Ligand CEO Higgins ties with Shkreli
The U.S. Senate Special Committee on Aging, led by Senators Susan Collins (R-ME) and Claire McCaskill (DMO), has properly investigated the fraudulent schemes of Martin Shkreli and the companies he founded,
Retrophin (a Ligand partner) and Turing Pharmaceuticals, which set out to obtain licenses on out-ofpatent medicines and increase the prices on them dramatically in pursuit of windfall profits without either
of Shkrelis companies needing to develop and bring its own drugs to market. Since markets for out-ofpatent drugs are often small, and obtaining regulatory approval to manufacture a generic version is
expensive, Shkreli calculated or perhaps was shown that, with closed distribution for the product and no
competition, his companies could set nearly limitlessly high prices for these drugs.
Less known, however, is the fact that it was Ligand CEO John Higgins who set Shkreli up as a biotech
executive in 2012,14 helping Shkreli establish this monopoly business model 15 at Retrophin through the
licensing of DARA (dual acting receptor antagonist of angiotensin and endothelin receptors) intended to
be developed for orphan indications of severe kidney disease16 from Ligand.
In fact, in 2012, announcing his partnership with Shkreli, Ligands Higgins issued a press release praising
Shkreli and the unethical monopoly business model that he helped Shkreli establish, stating:
This is an attractive deal for Ligand and our shareholders. We have partnered DARA
with a team that has great credentials, is highly motivated to advance the program
and has a compelling development plan. This is another valuable asset in our latestage portfolio. 17 and
The leadership at Retrophin has shown tremendous passion and commitment to
advance this important program, working with the FDA and raising additional
capital. 18
Shkreli, in turn, recently appeared as cognoscenti in an interview, praising Ligand as a very well run
business.19 In fact, Ligands relationship with Shkrelis is so close that Retrophin director John W. Kozarich
14
See: The next Sage? Shkreli partner Ligand puts together another sweet startup package deal for Seelos available
here: Link
15
See: Sudden Price Spikes in Decades-Old Rx Drugs: Inside the Monopoly Business Model available here: Link
16
See: Ligand Licenses DARA Program to Retrophin, available here: Link
17
See: Ligand Licenses DARA Program to Retrophin, available here: Link
18
See: Ligand receives equity milestone payment from Retrophin: Link
19
See: Martin Shkreli Thinks Jazz Pharmaceuticals Could Be Worth $20 Billion, While Mast Therapeutics Is
'Worthless available at the 10 minute, 45 second mark here: Link
simultaneously serves as Ligands chairman of the board. However, Higgins has been even more deceptive
than Shkreli since price hikes of Ligand drugs such as DARA are both carried out and buried in third-party
licensees, allowing Ligand to focus almost singularly on the task of sourcing new drug monopolies under
the Orphan Drug Act.
After the publication of our June 16, 2014 report criticizing Ligand, Roth Capital (a firm both Ligand
surrogate Viking20 and Shkrelis Retrophin utilize for underwriting21) vigorously defended Ligands
unethical business model. About two weeks later, on July 1, 2014, Roth Capital appeared as an
underwriter of the Viking IPO, which later would directly account for $28 million in ghost profits on
Ligands income statement as described above.
Conclusion
Ligand Pharmaceuticals free-for-all money grab, like Shkrelis Retrophin, Valeant and Mylan, has not
played out in a vacuum; it has real public policy and health-care ramifications for real patients, real
taxpayers and real shareholders.
The companys licensing model has multiplied its price gauging scheme exponentially and has, in turn,
held patients hostage, burdening the U.S. taxpayer, preventing generic competition, fleecing
shareholders and enriching Ligand executives. Even with Shkreli and former Valeant executives having
been arrested and charged with fraud in what the U.S. Department of Justice correctly labeled a trifecta
of lies, deceit and greed,22 and the Justice Department engaged in an ongoing multi-year federal antitrust
investigation into anticompetitive conduct in the pharmaceutical industry, Ligand CEO John Higgins, who
is the key node in this web of pharmaceutical industry malfeasance, is still shamelessly pushing the
unethical Ligand model forward at astonishing cost to patients, taxpayers, and investors.
20